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4. Camonsertib in DNA damage response-deficient advanced solid tumors: phase 1 trial results

Author

Yap, Timothy A., Fontana, Elisa, Lee, Elizabeth K., Spigel, David R., Højgaard, Martin, Lheureux, Stephanie, Mettu, Niharika B., Carneiro, Benedito A., Carter, Louise, Plummer, Ruth, Cote, Gregory M., Meric-Bernstam, Funda, O’Connell, Joseph, Schonhoft, Joseph D., Wainszelbaum, Marisa, Fretland, Adrian J., Manley, Peter, Xu, Yi, Ulanet, Danielle, Rimkunas, Victoria, Zinda, Mike, Koehler, Maria, Silverman, Ian M., Reis-Filho, Jorge S., and Rosen, Ezra

Published
2023
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6. Results From First-in-Human Phase I Dose-Escalation Study of a Novel Bicycle Toxin Conjugate Targeting EphA2 (BT5528) in Patients With Advanced Solid Tumors.

Author

Bashir, Babar, Wang, Judy S., Falchook, Gerald, Fontana, Elisa, Arkenau, Hendrik-Tobias, Carter, Louise, Galot, Rachel, Basu, Bristi, Greystoke, Alastair, Subbiah, Vivek, Richardson, Debra L., Orr, Hanna, Bennett, Gavin, Sharma, Rajiv, Xu, Hongmei, Paganoni, Paola, Xu, Cong, Campbell, Carly, and McKean, Meredith

Published
2024
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8. Ataxia telangiectasia and Rad3-related (ATR) inhibitor camonsertib dose optimization in patients with biomarker-selected advanced solid tumors (TRESR study).

Author

Fontana, Elisa, Rosen, Ezra, Lee, Elizabeth K, Højgaard, Martin, Mettu, Niharika B, Lheureux, Stephanie, Carneiro, Benedito A, Cote, Gregory M, Carter, Louise, Plummer, Ruth, Mahalingam, Devalingam, Fretland, Adrian J, Schonhoft, Joseph D, Silverman, Ian M, Wainszelbaum, Marisa, Xu, Yi, Ulanet, Danielle, Koehler, Maria, and Yap, Timothy A

Subjects
CIRCULATING tumor DNA, DNA repair, ATAXIA telangiectasia, BIOMARKERS, ADVERSE health care events
Abstract

Background Camonsertib is a selective oral inhibitor of ataxia telangiectasia and Rad3-related (ATR) kinase with demonstrated efficacy in tumors with DNA damage response gene deficiencies. On-target anemia is the main drug-related toxicity typically manifesting after the period of dose-limiting toxicity evaluation. Thus, dose and schedule optimization requires extended follow-up to assess prolonged treatment effects. Methods Long-term safety, tolerability, and antitumor efficacy of 3 camonsertib monotherapy dosing regimens were assessed in the TRESR study dose-optimization phase: 160 mg once daily (QD) 3 days on, 4 days off (160 3/4; the preliminary recommended Phase II dose [RP2D]) and two step-down groups of 120 mg QD 3/4 (120 3/4) and 160 mg QD 3/4, 2 weeks on, 1 week off (160 3/4, 2/1w). Safety endpoints included incidence of treatment-related adverse events (TRAEs), dose modifications, and transfusions. Efficacy endpoints included overall response rate, clinical benefit rate, progression-free survival, and circulating tumor DNA (ctDNA)-based molecular response rate. Results The analysis included 119 patients: 160 3/4 (n = 67), 120 3/4 (n = 25), and 160 3/4, 2/1w (n = 27) treated up to 117.1 weeks as of the data cutoff. The risk of developing grade 3 anemia was significantly lower in the 160 3/4, 2/1w group compared with the preliminary RP2D group (hazard ratio = 0.23, 2-sided P  = .02), translating to reduced transfusion and dose reduction requirements. The intermittent weekly schedule did not compromise antitumor activity. Conclusion The 160 3/4, 2/1w dose was established as an optimized regimen for future camonsertib monotherapy studies offering a substantial reduction in the incidence of anemia without any compromise to efficacy. Clinical Trial ID NCT04497116. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Lebrikizumab Maintains Improvements in the Patient-Oriented Eczema Measure Through 2 Years of Treatment in Patients With Moderate-to-Severe Atopic Dermatitis

Author

Rosmarin, David, primary, Wollenberg, Andreas, additional, Boguniewicz, Mark, additional, Jack, Carolyn, additional, Barbarot, Sebastien, additional, Shi, Vivian, additional, de Bruin-Weller, Marjolein, additional, DeLuca-Carter, Louise, additional, Pierce, Evangeline, additional, Hu, Chaoran, additional, Liu, Chunyuan, additional, Crane, Heidi, additional, Bardolet, Laia, additional, and Steinhoff, Martin, additional

Published
2024
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10. 494 - Efficacy and safety of lebrikizumab is maintained to two years in patients with moderate-to-severe atopic dermatitis

Author

Guttman-Yassky, Emma, primary, Weidinger, Stephan, additional, Simpson, Eric, additional, Gooderham, Melinda, additional, Irvine, Alan, additional, Spelman, Lynda, additional, Silverberg, Jonathan, additional, Elmaraghy, Hany, additional, DeLuca-Carter, Louise, additional, Piruzeli, Maria Lucia Buziqui, additional, Hu, Chaoran, additional, Yang, Fan Emily, additional, Pierce, Evangeline, additional, Bardolet, Laia, additional, and Thaci, Diamant, additional

Published
2024
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11. A biobank of small cell lung cancer CDX models elucidates inter- and intratumoral phenotypic heterogeneity

Author

Simpson, Kathryn L., Stoney, Ruth, Frese, Kristopher K., Simms, Nicole, Rowe, William, Pearce, Simon P., Humphrey, Sam, Booth, Laura, Morgan, Derrick, Dynowski, Marek, Trapani, Francesca, Catozzi, Alessia, Revill, Mitchell, Helps, Thomas, Galvin, Melanie, Girard, Luc, Nonaka, Daisuke, Carter, Louise, Krebs, Matthew G., Cook, Natalie, Carter, Mathew, Priest, Lynsey, Kerr, Alastair, Gazdar, Adi F., Blackhall, Fiona, and Dive, Caroline

Published
2020
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12. Efficacy and Safety of Lebrikizumab Is Maintained to Two Years in Patients With Moderate-to-Severe Atopic Dermatitis

Author

Guttman-Yassky, Emma, primary, Weidinger, Stephan, additional, Simpson, Eric, additional, Gooderham, Melinda, additional, Irvine, Alan, additional, Spelman, Lynda, additional, Silverberg, Jonathan, additional, Elmaraghy, Hany, additional, DeLuca-Carter, Louise, additional, Buziqui Piruzeli, Maria Lucia, additional, Hu, Chaoran, additional, Yang, Fan Emily, additional, Pierce, Evangeline, additional, Bardolet, Laia, additional, and Thaci, Diamant, additional

Published
2023
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14. Utility of ctDNA to support patient selection for early phase clinical trials: the TARGET study

Author

Rothwell, Dominic G., Ayub, Mahmood, Cook, Natalie, Thistlethwaite, Fiona, Carter, Louise, Dean, Emma, Smith, Nigel, Villa, Shaun, Dransfield, Joanne, Clipson, Alexandra, White, Daniel, Nessa, Kamrun, Ferdous, Saba, Howell, Matthew, Gupta, Avinash, Kilerci, Bedirhan, Mohan, Sumitra, Frese, Kris, Gulati, Sakshi, Miller, Crispin, Jordan, Allan, Eaton, Helen, Hickson, Nicholas, O’Brien, Ciara, Graham, Donna, Kelly, Claire, Aruketty, Sreeja, Metcalf, Robert, Chiramel, Jaseela, Tinsley, Nadina, Vickers, Alexander J., Kurup, Roopa, Frost, Hannah, Stevenson, Julie, Southam, Siobhan, Landers, Dónal, Wallace, Andrew, Marais, Richard, Hughes, Andrew M., Brady, Ged, Dive, Caroline, and Krebs, Matthew G.

Published
2019
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16. Mean plasma SRA737 concentration over time from A Phase I/II Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination with Low-Dose Gemcitabine in Patients with Advanced Cancer

Author

Jones, Robert, primary, Plummer, Ruth, primary, Moreno, Victor, primary, Carter, Louise, primary, Roda, Desamparados, primary, Garralda, Elena, primary, Kristeleit, Rebecca, primary, Sarker, Debashis, primary, Arkenau, Tobias, primary, Roxburgh, Patricia, primary, Walter, Harriet S., primary, Blagden, Sarah, primary, Anthoney, Alan, primary, Klencke, Barbara J., primary, Kowalski, Mark M., primary, and Banerji, Udai, primary

Published
2023
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17. Mean exposure (AUC0–12) by dose level from A Phase I/II Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination with Low-Dose Gemcitabine in Patients with Advanced Cancer

Author

Jones, Robert, primary, Plummer, Ruth, primary, Moreno, Victor, primary, Carter, Louise, primary, Roda, Desamparados, primary, Garralda, Elena, primary, Kristeleit, Rebecca, primary, Sarker, Debashis, primary, Arkenau, Tobias, primary, Roxburgh, Patricia, primary, Walter, Harriet S., primary, Blagden, Sarah, primary, Anthoney, Alan, primary, Klencke, Barbara J., primary, Kowalski, Mark M., primary, and Banerji, Udai, primary

Published
2023
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18. Data from A Phase I/II Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination with Low-Dose Gemcitabine in Patients with Advanced Cancer

Author

Jones, Robert, primary, Plummer, Ruth, primary, Moreno, Victor, primary, Carter, Louise, primary, Roda, Desamparados, primary, Garralda, Elena, primary, Kristeleit, Rebecca, primary, Sarker, Debashis, primary, Arkenau, Tobias, primary, Roxburgh, Patricia, primary, Walter, Harriet S., primary, Blagden, Sarah, primary, Anthoney, Alan, primary, Klencke, Barbara J., primary, Kowalski, Mark M., primary, and Banerji, Udai, primary

Published
2023
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19. Supplementary Methods. MS1 from A Phase I/II Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination with Low-Dose Gemcitabine in Patients with Advanced Cancer

Author

Jones, Robert, primary, Plummer, Ruth, primary, Moreno, Victor, primary, Carter, Louise, primary, Roda, Desamparados, primary, Garralda, Elena, primary, Kristeleit, Rebecca, primary, Sarker, Debashis, primary, Arkenau, Tobias, primary, Roxburgh, Patricia, primary, Walter, Harriet S., primary, Blagden, Sarah, primary, Anthoney, Alan, primary, Klencke, Barbara J., primary, Kowalski, Mark M., primary, and Banerji, Udai, primary

Published
2023
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20. Demographic and Disease Characteristics from A Phase I/II Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination with Low-Dose Gemcitabine in Patients with Advanced Cancer

Author

Jones, Robert, primary, Plummer, Ruth, primary, Moreno, Victor, primary, Carter, Louise, primary, Roda, Desamparados, primary, Garralda, Elena, primary, Kristeleit, Rebecca, primary, Sarker, Debashis, primary, Arkenau, Tobias, primary, Roxburgh, Patricia, primary, Walter, Harriet S., primary, Blagden, Sarah, primary, Anthoney, Alan, primary, Klencke, Barbara J., primary, Kowalski, Mark M., primary, and Banerji, Udai, primary

Published
2023
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28. BT8009-100: A phase I/II study of novel bicyclic peptide and MMAE conjugate BT8009 in patients (pts) with advanced malignancies associated with nectin-4 expression, including urothelial cancer (UC).

Author

Baldini, Capucine, primary, Goldschmidt, Vincent, additional, Brana, Irene, additional, Doger, Bernard, additional, Italiano, Antoine, additional, Cousin, Sophie, additional, Falchook, Gerald Steven, additional, Necchi, Andrea, additional, Reig, Oscar, additional, Carter, Louise, additional, Fontana, Elisa, additional, Verlingue, Loic, additional, Hazard, Sebastien, additional, Dickson, Amy, additional, Xu, Cong, additional, Xu, Hongmei, additional, Sharma, Rajiv, additional, Smethurst, Dominic, additional, and McKean, Meredith, additional

Published
2023
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30. A Phase I/II Trial of Oral SRA737 (a Chk1 Inhibitor) Given in Combination with Low-Dose Gemcitabine in Patients with Advanced Cancer

Author

Jones, Robert, primary, Plummer, Ruth, additional, Moreno, Victor, additional, Carter, Louise, additional, Roda, Desamparados, additional, Garralda, Elena, additional, Kristeleit, Rebecca, additional, Sarker, Debashis, additional, Arkenau, Tobias, additional, Roxburgh, Patricia, additional, Walter, Harriet S., additional, Blagden, Sarah, additional, Anthoney, Alan, additional, Klencke, Barbara J., additional, Kowalski, Mark M., additional, and Banerji, Udai, additional

Published
2022
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31. Molecular analysis of circulating tumor cells identifies distinct copy-number profiles in patients with chemosensitive and chemorefractory small-cell lung cancer

Author

Carter, Louise, Rothwell, Dominic G, Mesquita, Barbara, Smowton, Christopher, Leong, Hui Sun, Fernandez-Gutierrez, Fabiola, Li, Yaoyong, Burt, Deborah J, Antonello, Jenny, Morrow, Christopher J, Hodgkinson, Cassandra L, Morris, Karen, Priest, Lynsey, Carter, Mathew, Miller, Crispin, Hughes, Andrew, Blackhall, Fiona, Dive, Caroline, and Brady, Ged

Subjects
Molecular diagnostic techniques -- Innovations, Copy number variations -- Health aspects, Drug resistance -- Genetic aspects, Small cell lung cancer -- Genetic aspects -- Development and progression -- Care and treatment, Biological sciences, Health
Abstract

Author(s): Louise Carter [1]; Dominic G Rothwell [1]; Barbara Mesquita [1]; Christopher Smowton [1]; Hui Sun Leong [2]; Fabiola Fernandez-Gutierrez [1]; Yaoyong Li [3]; Deborah J Burt [1]; Jenny Antonello [...]

Published
2017
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35. Abstract CT030: Genomic and pathologic determinants of response to RP-3500, an ataxia telangiectasia and Rad3-related inhibitor (ATRi), in patients (pts) with DNA damage repair (DDR) loss-of-function (LOF) mutant tumors in the Phase 1/2 TRESR trial

Author

Yap, Timothy A., primary, Silverman, Ian M., additional, Fontana, Elisa, additional, Lee, Elizabeth, additional, Spigel, David, additional, Højgaard, Martin, additional, Lheureux, Stephanie, additional, Mettu, Niharika, additional, Carneiro, Benedito A., additional, Carter, Louise, additional, Plummer, Ruther, additional, Schonhoft, Joseph D., additional, Ulanet, Danielle, additional, Nejad, Parham, additional, Manley, Peter, additional, Reis-Filho, Jorge S., additional, Xu, Yi, additional, Rimkunas, Victoria, additional, Koehler, Maria, additional, and Rosen, Ezra, additional

Published
2022
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36. Circulating tumor DNA (ctDNA) determinants of improved outcomes in patients (pts) with advanced solid tumors receiving the ataxia telangiectasia and Rad3-related inhibitor (ATRi), RP-3500, in the phase 1/2a TRESR trial (NCT04497116).

Author

Rosen, Ezra, primary, Silverman, Ian M., additional, Fontana, Elisa, additional, Lee, Elizabeth Katherine, additional, Spigel, David R., additional, Højgaard, Martin, additional, Lheureux, Stephanie, additional, Mettu, Niharika B., additional, Carneiro, Benedito A., additional, Carter, Louise, additional, Plummer, Elizabeth Ruth, additional, Schonhoft, Joseph D., additional, Ulanet, Danielle, additional, Manley, Peter, additional, Reis-Filho, Jorge S., additional, Xu, Yi, additional, Rimkunas, Victoria, additional, Koehler, Maria, additional, and Yap, Timothy A., additional

Published
2022
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37. The Impact of Substance Use and Violence/Delinquency on Academic Achievement for Groups of Middle and High School Students in Washington.

Author

Washington Univ., Seattle. Human Services Policy Center., Mandell, Dorothy J., Hill, Sheri L., Carter, Louise, and Brandon, Richard N.

Abstract

Noting that little is known about how the social environment affects academic achievement among groups of students, this study examined the associations among substance use, violent/delinquent behavior, and academic achievement in groups of middle and high school students. Data sources for middle school students were the 1998 Washington State Survey of Adolescent Health Behaviors (WSSAHB) and the 1999 Washington Assessment of Student Learning; data sources for high school students included the WSSAHB and eleventh graders' averages on the Iowa Test of Basic Skills. Groups were defined by grade level, gender, and race/ethnicity. In order to more fully understand the dynamics linking risky non-classroom behavior to school performance, the study also examined the effects of poverty, attitudes, neighborhood characteristics, and social skills. Findings indicated that groups of middle and high school students with even moderate involvement with substance use and violence/delinquency had poorer overall achievement than groups of students with little or no involvement in these behaviors. For middle school students, behavior and attitudes about harmful behaviors were tightly linked (correlation =.96). High school students' attitudes and behaviors were closely related but not identical. Substance use was closely related to violence/delinquency. Poverty influenced student behavior, attitudes, and academic achievement. School resources did not predict substance use, violence/delinquency, or test scores. Risk and protective factors influenced substance use and violence/delinquency for both middle and high school students. Between 20 and 40 percent of Washington state middle and high school students reported the kinds of attitudes and behavior linked to impaired school performance. Numerous policy implications follow from the findings. Appended is a list of questions from the surveys used. (Contains 82 references.) (KB)

Published
2002

39. Tumorigenicity and genetic profiling of circulating tumor cells in small-cell lung cancer

Author

Hodgkinson, Cassandra L., Morrow, Christopher J., Li, Yaoyong, Metcalf, Robert L., Rothwell, Dominic G., Trapani, Francesca, Polanski, Radoslaw, Burt, Deborah J., Simpson, Kathryn L., Morris, Karen, Pepper, Stuart D., Nonaka, Daisuke, Greystoke, Alastair, Kelly, Paul, Bola, Becky, Krebs, Matthew G., Antonello, Jenny, Ayub, Mahmood, Faulkner, Suzanne, Priest, Lynsey, Carter, Louise, Tate, Catriona, Miller, Crispin J., Blackhall, Fiona, Brady, Ged, and Dive, Caroline

Subjects
Lung cancer, Small cell -- Genetic aspects -- Care and treatment -- Patient outcomes, Cancer cells -- Physiological aspects, Biological sciences, Health
Abstract

Small-cell lung cancer (SCLC), an aggressive neuroendocrine tumor with early dissemination and dismal prognosis, accounts for 15-20% of lung cancer cases and ~200,000 deaths each year. Most cases are inoperable, and biopsies to investigate SCLC biology are rarely obtainable. Circulating tumor cells (CTCs), which are prevalent in SCLC, present a readily accessible 'liquid biopsy'. Here we show that CTCs from patients with either chemosensitive or chemorefractory SCLC are tumorigenic in immune-compromised mice, and the resultant CTC-derived explants (CDXs) mirror the donor patient's response to platinum and etoposide chemotherapy. Genomic analysis of isolated CTCs revealed considerable similarity to the corresponding CDX. Most marked differences were observed between CDXs from patients with different clinical outcomes. These data demonstrate that CTC molecular analysis via serial blood sampling could facilitate delivery of personalized medicine for SCLC. CDXs are readily passaged, and these unique mouse models provide tractable systems for therapy testing and understanding drug resistance mechanisms., Improved treatment outcomes for patients with SCLC require new approaches to interrogate the biology and genetics of this disease, appropriate methods to investigate resistance to current chemotherapy and tractable, patient-derived, [...]

Published
2014
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41. Abstract CC04-01: First-in-human biomarker-driven phase I TRESR trial of ataxia telangiectasia and Rad3-related inhibitor (ATRi) RP-3500 in patients (pts) with advanced solid tumors harboring synthetic lethal (SL) genomic alterations

Author

Yap, Timothy, primary, Lee, Elizabeth, additional, Spigel, David, additional, Fontana, Elisa, additional, Højgaard, Martin, additional, Lheureux, Stephanie, additional, Mettu, Niharika B., additional, Carter, Louise, additional, Plummer, Ruth, additional, Ulanet, Danielle, additional, Manley, Peter, additional, Jiang, Ying, additional, and Rosen, Ezra, additional

Published
2021
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50. Differential response rates in early-phase cancer clinical trials (EPCCT).

Author

Abdul Rahman, Rozana, primary, Billy Graham Mariam, Neethu, additional, Mistry, Hitesh, additional, Aruketty, Sreeja, additional, Church, Matt, additional, Adamson-Raieste, Aidi, additional, Scott, Julie-Anne, additional, Thistlethwaite, Fiona, additional, Krebs, Matthew, additional, Carter, Louise, additional, Graham, Donna M., additional, and Cook, Natalie, additional

Published
2021
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