Neoplasms

All Conditions

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Stomach Neoplasms

Esophageal Neoplasms

Uterine Cervical Neoplasms

Melanoma

Carcinoma, Transitional Cell

Stomach Cancer

Esophageal Cancer

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Participants in successive cohorts will receive escalating doses of RO7502175, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ia Dose Escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Participants in successive cohorts will receive escalating doses of RO7502175, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ib Dose Escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

RO7502175 will be administered as per the schedules specified in the respective arms.

RO7502175

Atezolizumab will be administered as per the schedules specified in the respective arms.

Reference Study ID Number: GO43860 https://forpatients.roche.com/

This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Genentech, Inc.

Symptoms and General Pathology

Nervous System Diseases

Heart and Blood Diseases

Diseases and Abnormalities at or Before Birth

Syndrome

Carcinoma, Renal Cell

Von Hippel-Lindau Disease

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neurocutaneous Syndromes

Angiomatosis

Vascular Diseases

Ciliopathies

Congenital Abnormalities

Abnormalities, Multiple

Genetic Diseases, Inborn

Renal Cell Carcinoma

Twenty-five patients will be enrolled in each stage of a two-stage design

PT2385 inhibits HIF-2α and is a novel approach to treatment of VHL disease-associated ccRCC.

PT2385 Tablets

Medical Director

The primary objective of this study is to assess the overall response rate (ORR) of von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC) tumors in VHL patients treated with PT2385.

This open-label Phase 2 study will evaluate the efficacy, safety, PK, and PD of PT2385 in patients with VHL disease who have at least 1 measurable VHL disease-associated ccRCC tumor (as defined by RECIST 1.1). PT2385 will be administered orally and treatment will be continuous. Changes in VHL disease-associated non-ccRCC tumors will also be evaluated.

This is an open-label Phase 2 study that will be conducted with a 2-stage design.

PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma

An Open Label Phase 2 Study to Evaluate PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Overall response rate (ORR) in VHL disease-associated ccRCC tumors

Progression free survival (PFS) in VHL disease-associated ccRCC tumors

Duration of response (DOR) in VHL disease-associated ccRCC tumors

Time to response (TTR) in VHL disease-associated ccRCC tumors

An AE is defined as any untoward medical occurrence in a patient regardless of its causal relationship to study treatment. An AE can be any unfavorable and unintended sign (including any clinically significant abnormal laboratory test result), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered to be study drug related.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors	NCT05581004	Locally Advance... NSCLC HNSCC Melanoma TNBC Esophageal Canc... Gastric Cancer Cervical Cancer Urothelial Carc... Clear Cell RCC HCC	RO7502175 Atezolizumab	18 Years -	Genentech, Inc.
PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma	NCT03108066	VHL Gene Mutati... VHL VHL Syndrome VHL Gene Inacti... Von Hippel Von Hippel-Lind... Von Hippel's Di... Von Hippel-Lind... Clear Cell Rena... Clear Cell RCC ccRCC	PT2385 Tablets	18 Years -	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors	NCT05581004	Locally Advance... NSCLC HNSCC Melanoma TNBC Esophageal Canc... Gastric Cancer Cervical Cancer Urothelial Carc... Clear Cell RCC HCC	RO7502175 Atezolizumab	18 Years -	Genentech, Inc.
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors	NCT05581004	Locally Advance... NSCLC HNSCC Melanoma TNBC Esophageal Canc... Gastric Cancer Cervical Cancer Urothelial Carc... Clear Cell RCC HCC	RO7502175 Atezolizumab	18 Years -	Genentech, Inc.

Spots Global Cancer Trial Database for clear cell rcc