E. Claire Dees

Phase 1 clinical trial of the ataxia telangiectasia and Rad3‐related inhibitor berzosertib with irinotecan in patients with advanced solid tumors (ETCTN 9938)

Liza C. Villaruz, Jingxiao Jin, Hong Wang, James J. Lee et autres

ABSTRACT Background Ataxia telangiectasia and Rad3‐related (ATR) inhibition with berzosertib potentiates the efficacy of irinotecan in preclinical models. The authors hypothesize that this combination is well tolerated, modulates the DNA damage response to irinotecan, and is associated with clinical activity in advanced …

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Phase 1/2 study of H3B-6545 in women with locally advanced/metastatic estrogen receptor-positive, HER2-negative breast cancer

Nisha Unni, Pamela N. Münster, Kohei Yamaguchi, Aki Morikawa et autres

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Phase 1/2 study of H3B-6545 in women with locally advanced/metastatic estrogen receptor-positive, HER2-negative breast cancer

Erika Hamilton, Timothy Pluard, Judy S. Wang, Aki Morikawa et autres

BACKGROUND: Although endocrine therapies, alone or in combination with CDK4/6 inhibitors, have led to notable improvements in the treatment of estrogen receptor-positive (ER+) breast cancer, progression is inevitable for most patients. We report dose escalation and expansion data from a trial of …

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Abstract P4-08-25: Overall survival in patients with HR+/HER2- advanced breast cancer treated in a phase 1b trial evaluating gedatolisib in combination with palbociclib and endocrine therapy

Rachel M. Layman, Hope S. Rugo, Robert Wesolowski, Hyo S. Han et autres

Abstract Background: Gedatolisib is a pan PI3K/mTOR inhibitor and was evaluated in a multicenter, open-label, phase 1b dose-escalation and dose-expansion trial in combination with palbociclib and endocrine therapy in patients with hormone receptor-positive/HER-2 negative (HR+/HER2-) breast cancer with varying categories of prior …

Abstract CT241: A phase 1, first-in-human (FIH) study of autologous anti-HER2 chimeric antigen receptor macrophage (CAR-M) in participants (pt) with HER2 overexpressing solid tumors

Yara Abdou, E. Claire Dees, Joanne Mortimer, Naoto T. Ueno et autres

Abstract Background: Macrophages are abundant in the solid tumor microenvironment (sTME) and can exhibit both pro- and anti-tumor functions. Macrophages can be redirected by CAR expression to phagocytose cancer cells in an antigen-specific manner. CAR-M can reprogram the sTME and present neoantigens …

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Abstract PD13-05: PD13-05 Updated results of a Phase 1b study of gedatolisib plus palbociclib and endocrine therapy in women with hormone receptor positive advanced breast cancer: Subgroup analysis by PIK3CA mutation status

Robert Wesolowski, Hope Rugo, Erica Stringer-Reasor, Hyo S. Han et autres

Abstract Background: Addition of PI3K/mTOR inhibitor after progression on CDK4/6 inhibitor (CDK4/6i) and endocrine therapy (ET) can potentially restore sensitivity to CDK4/6i and prevent adaptive activation of the PI3K/mTOR pathway. To evaluate this hypothesis, we conducted a Phase Ib study of gedatolisib …

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Abstract P1-17-10: H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer - A phase II study

Erika Hamilton, Judy S. Wang, Timothy Pluard, Aki Morikawa et autres

Abstract Purpose: H3B-6545, a novel Selective ERα Covalent Antagonist (SERCA), inactivates both and wild-type and mutant ERα by targeting cysteine 530 and enforcing antagonist conformation. H3B-6545 demonstrated preclinical high activity in breast cancer models with constitutively active ESR1 mutations (Furman C, SABCS …

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Abstract PD8-07: Pharmacodynamic analysis from a phase 1 study of rintodestrant (G1T48), an oral selective estrogen receptor degrader, in ER+/HER2- locally advanced or metastatic breast cancer

Philippe Aftimos, Marina Maglakelidze, Andor W.J.M. Glaudemans, Erika Hamilton et autres

Abstract Background: Rintodestrant is an orally bioavailable, potent and selective estrogen receptor degrader (SERD) that inhibits estrogen receptor (ER) gene transcription, degrades the ER, and delays tumor proliferation in preclinical models. Preliminary results from Part 1 dose escalation (200-1000 mg once daily) …

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Abstract PS12-04: Rintodestrant (G1T48), an oral selective estrogen receptor degrader in ER+/HER2- locally advanced or metastatic breast cancer: Updated phase 1 results and dose selection

Philippe Aftimos, Patrick Neven, Mark D. Pegram, C. Willemien Menke‐van der Houven van Oordt et autres

Abstract Background: Rintodestrant (G1T48) is a potent oral selective estrogen receptor degrader (SERD) that competitively binds to the estrogen receptor (ER) and blocks ER signaling in tumors resistant to other endocrine therapies. Preliminary results from Part 1 dose escalation showed robust target …

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Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Washout Period and Concomitant Medication Work Group

R. Donald Harvey, Kathryn F. Mileham, Vishal Bhatnagar, Jamie R. Brewer et autres

Abstract Purpose: Washout periods and concomitant medication exclusions are common in cancer clinical trial protocols. These exclusion criteria are often applied inconsistently and without evidence to justify their use. The authors sought to determine how washout period and concomitant medication allowances can …

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A first in man phase I trial of the oral immunomodulator, indoximod, combined with docetaxel in patients with metastatic solid tumors

Daniel M. Sullivan, Roohi Ismail‐Khan, Hatem Soliman, Scott Antonia et autres

BackgroundIndoleamine 2,3-dioxygenase (IDO) is an enzyme that tumors use to create a state of immunosuppression. Indoximod is an IDO pathway inhibitor. Preclinical studies demonstrated that indoximod combined with chemotherapy was synergistic in a mouse model of breast cancer. A phase I 3+3 …

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A phase I and pharmacologic study of the combination of bortezomib and pegylated liposomal doxorubicin in patients with refractory solid tumors

Dixie Esseltine, Celeste Lindley, Frances A. Collichio, Lisa A. Carey et autres

Pre-clinical studies combining the proteasome inhibitor bortezomib with anthracyclines have shown enhanced anti-tumor activity. We therefore conducted a phase I trial of bortezomib and pegylated liposomal doxorubicin (PLD) in patients with refractory solid tumors.

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