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NCT06619587 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

A Phase 1 study of Solid Tumor, sponsored by Genentech.

Recruiting
Registry status
Phase 1
Development phase
410
Enrollment target
20
Study locations

NCT06619587 is a Phase 1 study of Solid Tumor that is actively recruiting participants, run by Genentech. The registered enrollment target is 410 participants, above the 220-participant average among 196 other Solid Tumor trials with a reported enrollment target (86% higher). The trial reports 20 study locations across 16 states.

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The verdict

NCT06619587, a Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Genentech.

RECRUITING
Registry status
Phase 1
Development phase
410 participants
Enrollment target
20
Study locations

Study Summary

This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.

Conditions Studied

Solid Tumor

Interventions

  • DRUG Phase I Arm A
  • DRUG Phase I Arm B

Study Locations (20)

Other

  • Rambam Health Care Campus - Haifa
  • Hadassah University Hospital - Ein Kerem - Jerusalem
  • The Chaim Sheba Medical Center - Ramat Gan
  • Tel Aviv Sourasky Medical Center PPDS - Tel Aviv

Pennsylvania

  • Mary Crowley Medical Research Center - Dallas
  • Abramson Cancer Center;Univ of Pennsylvania - Philadelphia

California

  • UC San Diego Moores Cancer Center - La Jolla

Colorado

  • Sarah Cannon Research Institute at HealthONE - Denver

Connecticut

  • Yale Cancer Center - New Haven

Florida

  • Florida Cancer Specialist-Lake Mary - Lake Mary

Illinois

  • University of Illinois - Chicago

Massachusetts

  • Dana Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 410 participants
Start Date 2024-11-14
Est. Completion 2028-05-31
Phase Phase 1

Sponsor

Genentech

332 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06619587

The ClinicalTrials.gov registry entry for NCT06619587 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 410 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 220-participant average among 196 other Solid Tumor trials with a reported enrollment target (86% higher). The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Phase I Arm A is the first listed.

NCT06619587 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, Pennsylvania, California.

Frequently Asked Questions

What is clinical trial NCT06619587 about?

NCT06619587 is a clinical study titled "A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors". This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic ...

What is the current status of trial NCT06619587?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 410 participants. The study started on 2024-11-14. Estimated completion is 2028-05-31.

What conditions does trial NCT06619587 study?

This clinical trial studies the following conditions: Solid Tumor.

What interventions are being tested in trial NCT06619587?

The interventions under investigation include: Phase I Arm A (DRUG), Phase I Arm B (DRUG).

Who is sponsoring clinical trial NCT06619587?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06619587 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.