Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Eith… (NCT05954871) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer
United States, Australia, South Korea10 participantsStarted 2024-01-08
Plain-language summary
The main purpose of the study is to evaluate the safety of GDC-1971 in combination with either osimertinib or cetuximab. The study consists of a dose-finding stage followed by an expansion stage.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Evaluable or measurable disease per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of ≥12 weeks
* Adequate hematologic and organ function within 14 days prior to initiation of study Inclusion Criteria for Non-Small Cell Lung Cancer Cohorts
* Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the lung that has progressed on/after prior treatment with third-generation epidermal growth factor receptor (EGFR) inhibitor (e.g., osimertinib)
* Positive for an EGFR exon 19 deletion or exon 21 L858R mutation
* Negative for acquired on-target EGFR alterations Inclusion Criteria for Colorectal Cancer Cohorts
* Histologically confirmed metastatic adenocarcinoma of the colon or rectum that has progressed on/after prior treatment with an EGFR inhibitor (e.g., cetuximab or panitumumab)
* Negative for kirsten rat sarcoma viral oncogene homolog (KRAS) alterations
* Negative for neuroblastoma RAS viral oncogene homolog (NRAS) alterations
* Negative for proto-oncogene B-Raf (BRAF) V600E alterations
* In lieu of a fresh pre-treatment biopsy, a recently obtained biopsy performed after completion of osimertinib therapy will be acceptable
Exclusion Criteria:
* Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 3 weeks or 5 drug elimination half-lives, whichever is shorter, prior to initiation of study treatment
* T…
What they're measuring
1
Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Timeframe: Up to approximately 41 months
2
Number of Participants with Dose-Limiting Toxicities (DLTs)
Timeframe: Day 1 through Day 28 of Cycle 1 (1cycle= 28 days)