Neoplasms

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Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

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Immunoproliferative Disorders

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Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Gemcitabine

Docetaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

AG-270 will be administered on Days 1 to 28 of each 28-day cycle. Treatment will continue until disease progression or unacceptable toxicity.

AG-270 will be administered daily, starting 1 week prior to docetaxel infusion. Starting on Cycle 1 Day 1, docetaxel (by intravenous infusion \[IV\]) will be administered once during each 21-day cycle. Treatment with AG-270 and docetaxel will continue until disease progression or unacceptable toxicity.

AG-270 will be administered daily, starting 1 week prior to nab-paclitaxel and gemcitabine infusion. Starting on Cycle 1 Day 1, nab-paclitaxel and gemcitabine IV will be administered on Days 1,8, and 15 during each 28-day cycle. Treatment with AG-270, nab-paclitaxel, and gemcitabine will continue until disease progression or unacceptable toxicity.

AG-270, orally, once or twice daily, on Days 1 through 28 of each 28-day cycle, until disease progression or unacceptable toxicity.

AG-270

AG-270, orally, once or twice daily, for 1 week prior to the first dose of docetaxel. Thereafter, AG-270 continues to be given daily, on Days 1 through 21 of each 21-day cycle, until disease progression or unacceptable toxicity.

AG-270, orally, once or twice daily for 1 week prior to the first doses of nab-paclitaxel and gemcitabine. Thereafter, AG-270 continues to be given daily on Days 1 through 28 of each 28-day cycle, until disease progression or unacceptable toxicity.

Docetaxel, IV, once during each 21-day cycle, until disease progression or unacceptable toxicity.

docetaxel

Nab-paclitaxel, IV, on Days 1, 8, and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.

nab-paclitaxel

Gemcitabine, IV, on Days 1, 8, and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.

gemcitabine

This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of AG-270 in participants with advanced solid tumors or lymphoma with homozygous MTAP deletion.

The purpose of this Phase 1, multicenter, open-label study is to determine the maximum tolerated dose (MTD) of AG-270, administered as a single agent or in combination with taxane-based chemotherapy, and to characterize its dose-limiting toxicities (DLTs) when given daily by mouth to participants with advanced solid tumors or lymphoma with homozygous deletion of methylthioadenosine phosphorylase (MTAP).

In each arm of the study, successive cohorts of participants will receive increasing oral doses of AG-270 to determine the MTD, the dose with maximum pharmacologic activity or the maximum feasible dose, as a single agent and in combination with taxane-based chemotherapy. In the subsequent dose-expansion parts of the study, additional participants in each treatment arm will be treated at the MTD (or one of the described alternative doses) to further characterize that dose's safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and to detect preliminary evidence of anti-tumor activity.

Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss

A Phase 1 Study of AG-270 in the Treatment of Subjects With Advanced Solid Tumors or Lymphoma With Homozygous Deletion of MTAP

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

* sponsored by Servier
* with a first patient enrolled as of 1 January 2004 onwards
* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

Institut de Recherches Internationales Servier

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Lung Neoplasms

Urinary Bladder Neoplasms

Sacituzumab govitecan

Immunoconjugates

Immunologic Factors

IDE397

IDEAYA Clinical Trials

Maroof Khan Zafar

New Patient Services

Teresa Lund

Estefania Bobe Cortes

Heather Flynn

Carol Goldener

Kailene Sullivan

Brandon Smith

Benjamin Herzberg, MD

Alexandra Mavracick

Christina Seunath

Benedito Carneiro

askSARAH

Jordi Rodon, MD

Carmen Gonzalez

Jia Liu

Ganessan Kichenadasse

Antoine Italiano

Eulalie Magne

Laurent Greillier

Thibault De la Motte Rouge

Frank Knauer

Ki Hyeong Lee

Ji-Youn Han

Joo-Hang Kim

Hye Ryun Kim

Changmin Choi

Montserrat Pequera Juvany

Elisa Lorente

Marta Benitez

Jorge Mercado

Laura Bailach

Ya-Zong Hsu

Chia-Chi Lin

Jasgit Sachdev, MD

This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with other anticancer agents including taxanes (docetaxel, paclitaxel), or sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors

Incidence of DLTs of IDE397 will be determined

Incidence of DLTs of IDE397 in a combination setting will be determined

MTD and RP2D of IDE397 will be determined

MTD and RP2D of IDE397 in a combination setting will be determined

Objective Response Rate (ORR) and Duration of Response (DoR)

Pharmacokinetics of IDE397 and metabolite following single and multiple oral administration as a single agent and in combination with docetaxel or paclitaxel or sacituzumab govitecan, will be determined

Pharmacokinetics of docetaxel or paclitaxel or sacituzumab govitecan.

Changes in the levels of MAT2A pathway and PRMT5 pathway will be determined

Objective response rate and duration of response will be assessed by Investigator using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

IDEAYA Biosciences

S095035 will be taken orally once daily in 28-day cycle.

S095035

Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department

This is a first-in-human Phase 1, multicenter, open-label dose escalation study of S095035 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \[MAT2A\] inhibitor.

S095035 in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene

A Phase 1, Open-label, Multicenter Clinical Trial of S095035 (MAT2A Inhibitor) in Adult Participants With Advanced or Metastatic Solid Tumors With Homozygous Deletion of MTAP

Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment

CBR=complete response \[CR\]+partial response \[PR\]+stable disease \[SD\] ) ≥6 months, Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment

Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment. The time from date of first documented confirmed CR or confirmed PR to date of first documented disease progression or death due to any cause.

Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per the investigator's assessment. The time from the date of randomization to date of first documented confirmed complete response (CR) or confirmed partial response (PR).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss	NCT03435250	Advanced Solid ... Lymphoma	AG-270 AG-270 AG-270 docetaxel nab-paclitaxel gemcitabine	18 Years -	Servier
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion	NCT04794699	Solid Tumor	IDE397 Docetaxel Paclitaxel Sacituzumab gov...	18 Years -	IDEAYA Biosciences
Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss	NCT03435250	Advanced Solid ... Lymphoma	AG-270 AG-270 AG-270 docetaxel nab-paclitaxel gemcitabine	18 Years -	Servier
S095035 in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of the Methylthioadenosine Phosphorylase (MTAP) Gene	NCT06188702	MTAP-deleted So...	S095035	18 Years -	Servier

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