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

NCT06619587
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
410
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Lead sponsor
Genentech, Inc.
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Start date
2024-11-14
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Number of sites
42
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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.
clinicaltrials.gov
Short title
A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
clinicaltrials.gov
Official title
A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation
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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
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-05-31
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First posted
2024-10-01
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Registry last updated
2026-08-25
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Primary completion date
2028-05-31
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Start date
2024-11-14
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Participants
410
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Participant count basis
Estimated
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Planned participants
410
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Protocol amendments
1
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Number of sites
42
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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
NCT06619587
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ClinicalTrials.gov ID
NCT06619587
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale

    Timeframe: 4 Years

  2. Percentage of Participants with Dose Limiting Toxicity

    Timeframe: 4 Years

  1. Plasma Concentrations of GDC-7035 at Specified Timepoints

    Timeframe: 4 Years

  2. Blood Concentrations of GDC-7035 at Specified Timepoints

    Timeframe: 4 Years

  3. Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal

    Timeframe: 4 Years

  4. Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal

    Timeframe: 4 Years

  5. Objective Response Rate Among Participants

    Timeframe: 4 Years

  6. Duration of Response Among Participants

    Timeframe: 4 Years

  7. Median Progression Free Survival Time Among Participants

    Timeframe: 4 Years

Sources for outcomes
clinicaltrials.gov

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

  • Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
  • Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

  • Malabsorption or other condition that would interfere with enteral absorption
  • Active brain metastases
  • Clinically significant cardiovascular dysfunction or liver disease
Sources for eligibility
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  • UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting
  • Sarah Cannon Research Institute at HealthONEDenver, United StatesRecruiting
  • Yale Cancer CenterNew Haven, United StatesRecruiting
  • Florida Cancer Specialist-Lake MaryLake Mary, United StatesCompleted
  • University of IllinoisChicago, United StatesRecruiting
  • Dana Farber Cancer InstituteBoston, United StatesRecruiting
  • START - Midwest - EDOSGrand Rapids, United StatesRecruiting
  • Montefiore Einstein Cancer CenterThe Bronx, United StatesRecruiting
  • Mary Crowley Medical Research CenterDallas, United StatesRecruiting
  • Abramson Cancer Center;Univ of PennsylvaniaPhiladelphia, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • O'Quinn Medical Tower at McNair CampusHouston, United StatesRecruiting
  • St Vincent's Hospital SydneyDarlinghurst, AustraliaRecruiting
  • Slade Health Inward goodsMount Kuring-Gai, AustraliaRecruiting
  • Peter Maccallum Cancer CentreParkville, AustraliaRecruiting
  • British Columbia Cancer AgencyVancouver, CanadaRecruiting
  • Princess Margaret Cancer CentreToronto, CanadaRecruiting
  • Sir Mortimer B Davis Jewish General HospitalMontreal, CanadaRecruiting
  • Gustave RoussyVillejuif, FranceRecruiting
  • Institut BergonieBordeaux, FranceRecruiting
  • Centre Georges Francois LeclercDijon, FranceRecruiting
  • Rambam Health Care CampusHaifa, IsraelRecruiting
  • Hadassah University Hospital - Ein KeremJerusalem, IsraelRecruiting
  • The Chaim Sheba Medical CenterRamat Gan, IsraelRecruiting
  • Tel Aviv Sourasky Medical Center PPDSTel Aviv, IsraelRecruiting

And 17 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)