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RecruitingPhase 1 / Phase 2

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests GTAEXS617 (REC-617) in people with certain advanced solid tumors. It looks at safety, side effects, how the body handles the drug, and how well it fights cancer.

The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be fully active or able to do light work, and be expected to live more than 3 months.
  • Have a cancer confirmed by tissue or cell testing: certain head and neck cancers, pancreatic adenocarcinoma, or non-small cell lung cancer.
  • Other allowed cancers include triple-negative breast cancer, or HR-positive, HER2-negative breast cancer that worsened after a CDK4/6 inhibitor medicine.
  • Certain high-grade cancers of the ovary, fallopian tube, or belly lining are also allowed if they resist platinum-based chemotherapy.
  • After standard treatment, have cancer that cannot be cured with surgery or radiation, has come back, or has spread.
  • Have blood counts, liver function, and kidney function that meet study requirements.
  • Have a tumor outside the bones that can be sampled with a biopsy, a test that removes a small piece of tissue.

Who can't join

  • Have an active infection that causes important health problems.
  • Have ongoing nausea, vomiting, bowel disease, or problems after bowel surgery that prevent enough of the study drug from being absorbed.
  • Have cancer in the brain or spinal cord that causes symptoms, or have another active or past cancer.
  • Have had an organ transplant or a stem-cell transplant from a donor.
  • Have moderate or severe heart or blood vessel disease.
  • Have received cancer treatment within 28 days or 5 drug half-lives before the first study dose, whichever is shorter. A half-life is the time it takes the body to clear half of a drug.
  • Have taken certain medicines that affect drug breakdown or transport within 14 days or 5 drug half-lives before the first dose. The study team must check these medicines.
  • Have serious side effects from past chemotherapy or radiation that have not cleared or become stable, or have had or plan to have major surgery less than 28 days before the first dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Life expectancy \> 3 months. * One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive \[HR+\] and Human Epidermal Growth Receptor 2 negative \[HER2-\] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)/ Cyclin-Dependent Kinase 6 \[CDK6\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC). * Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments. * Adequate hematological, liver, and renal function. * Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases. Key Exclusion Criteria: * Active and clinically significant (CS) infection. * Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617. * Symptomatic central nervous system (CNS) malignancy or metastases. * Concurrent active or previous malignancy. * Prior organ or allogeneic stem-cell transplantation. * Moderate or severe cardiovascular disease. * Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment. * Received treatment with known strong/moderate inhibitors and/or strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment. * Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment. * Received treatment with known substrates of organic anion transporting peptide or BCRP within 14 days or 5 half-lives before the first dose of study treatment. * Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy * Has had or is scheduled to have major surgery \<28 days prior to the first dose of study treatment. Note: Other protocol Inclusion/Exclusion criteria may apply.

Study sites (6)

CA

MI

NY

OH

TX

UT