A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma

NCT07859085
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Phase
Phase 1
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Recruitment status
Not yet recruiting
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Participants
388
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Lead sponsor
Genentech, Inc.
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Start date
2026-10-31
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Summary
The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). The study consists of a safety run-in period followed by a randomized/expansion period.
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Short title
A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
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Official title
A Phase Ib, Multicenter, Randomized Study Evaluating the Safety and Activity of GDC-7035 With Anti-Cancer Therapies as First-Line Treatment in Patients With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-03-30
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First posted
2026-10-05
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Registry last updated
2026-10-13
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Primary completion date
2029-03-30
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Start date
2026-10-31
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Participants
388
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Participant count basis
Estimated
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Planned participants
388
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Genentech, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07859085
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ClinicalTrials.gov ID
NCT07859085
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants With Adverse Events (AEs)

    Timeframe: Up to approximately 30 months

  2. Number of Participants With Key Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: Up to Day 28

  1. Objective Response Rate (ORR)

    Timeframe: Up to approximately 30 months

  2. Duration of Response (DOR)

    Timeframe: Up to approximately 30 months

  3. Progression-free Survival (PFS) After Randomization

    Timeframe: Up to approximately 30 months

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testing
  • Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

  • Malabsorption syndrome or other conditions that would interfere with enteral absorption
  • Known and untreated, or active central nervous system (CNS) metastases
  • Known clinically significant liver disease
  • History of or active clinically significant cardiovascular dysfunction

Other protocol-defined inclusion/exclusion criteria may apply.

Sources for eligibility
clinicaltrials.gov

Other registry identifiers

  • 2026-525460-17-00
Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Lead sponsors (1)

Conditions (2)

Targets (3)