OncoMatch/Clinical Trials/NCT04693468
Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial
Is NCT04693468 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Axitinib and Crizotinib for advanced malignant solid neoplasm.
Treatment: Axitinib · Crizotinib · Palbociclib Isethionate · Talazoparib Tosylate — This phase Ib trial is to find out the best dose, possible benefits and/or side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). PARPs are proteins that help repair damaged DNA, the genetic material that serves as the body's instruction book. PARP inhibitors, such as talazoparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Palbociclib, axitinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving talazoparib in combination with palbociclib, axitinib, or crizotinib may help control locally advanced or metastatic solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: BRCA1 pathogenic mutation
Defect in DNA Damage Response (DDR) genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes
Required: BRCA2 pathogenic mutation
Defect in DNA Damage Response (DDR) genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes
Required: PALB2 pathogenic mutation
Defect in DNA Damage Response (DDR) genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes
Required: RAD51C pathogenic mutation
Defect in DNA Damage Response (DDR) genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes
Required: RAD51D pathogenic mutation
Defect in DNA Damage Response (DDR) genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes
Required: MYC aberrant (overexpression, amplification, mutation)
MYC-aberrant solid tumors (e.g. overexpression, amplification, mutation)
Required: MET mutation
Solid tumors with defects in MET, ALK or ROS1 (e.g. MET mutations or amplifications, high MET expression, ALK translocations, ROS1 translocations)
Required: MET amplification
Solid tumors with defects in MET, ALK or ROS1 (e.g. MET mutations or amplifications, high MET expression, ALK translocations, ROS1 translocations)
Required: MET high expression (high)
Solid tumors with defects in MET, ALK or ROS1 (e.g. MET mutations or amplifications, high MET expression, ALK translocations, ROS1 translocations)
Required: ALK translocation
Solid tumors with defects in MET, ALK or ROS1 (e.g. MET mutations or amplifications, high MET expression, ALK translocations, ROS1 translocations)
Required: ROS1 translocation
Solid tumors with defects in MET, ALK or ROS1 (e.g. MET mutations or amplifications, high MET expression, ALK translocations, ROS1 translocations)
Required: BRCA1 wild-type
Participants with BRCA1/2 wild-type high-grade serous ovarian cancer
Required: BRCA2 wild-type
Participants with BRCA1/2 wild-type high-grade serous ovarian cancer
Disease stage
Metastatic disease required
Have measurable disease at study enrollment as defined by RECIST v1.1 with at least 1 measurable lesion that has not previously been irradiated; or participants may have bone metastatic disease evaluable by Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration-resistant prostate cancer (mCRPC), or according to the tumor evaluation criteria best suited and accepted for the tumor type being evaluated
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-cancer therapy
Exception: Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed at least 2 days prior to study enrollment and no clinically significant toxicities are expected (e.g. mucositis, esophagitis).
Prior anti-cancer therapy within 2 weeks prior to study enrollment or prior radiation therapy within 2 weeks prior to study enrollment.
Lab requirements
Blood counts
Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 or ≥ 1.5 x 10^9/L; Platelets ≥ 100,000/mm3 or ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L). Without hematopoietic growth factor or transfusion support within 14 days prior to study enrollment.
Kidney function
Estimated creatinine clearance (CRCL) ≥ 60 mL/min OR normal creatinine as assessed by 24h urine assessment (not both) required during dose-escalation phase. Patients with moderate renal impairment (30 - 59 mL/min) considered during dose expansion phase.
Liver function
Total serum bilirubin ≤ 1.5 x the upper limit of normal range (ULN); Aspartate and Alanine aminotransferase (AST and ALT) ≤ 5 x ULN.
Adequate bone marrow function... Adequate renal function... Adequate liver function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify