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Not yet recruiting NCT07703878

A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors

Phase I Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GS-1206.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GS-1206 in Adults With Solid Tumors

Overview

The goal of this clinical study is to learn more about the study drug GS-1206, including its safety, tolerability, and antitumor activity in adult participants with solid tumors.

Interventions

  • Drug GS-1206
    Administered Orally

Primary outcome measures

  • Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) [Time frame: First dose up to 21 days post first dose]
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0. [Time frame: First dose date up to 30 days post last dose (Up to 3 years)]
  • Percentage of Participants Experiencing Clinical Laboratory Abnormalities Based National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0. [Time frame: First dose date up to 30 days post last dose (Up to 3 years)]
Secondary outcome measures (9)
  • Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration [Time frame: Predose and postdose up to end of treatment (up to 2 years)]
  • Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites [Time frame: Up to 2 years]
  • PK Parameter: Tmax of GS-1206 and its Metabolites [Time frame: Up to 2 years]
  • PK Parameter: AUC0-24h of GS-1206 and its Metabolites [Time frame: Up to 2 years]
  • Objective Response Rate (ORR) [Time frame: Up to 3 years]
  • Duration of Response (DOR) [Time frame: Up to 3 years]
  • Best Overall Response (BOR) [Time frame: Up to 3 years]
  • Progression-Free Survival (PFS) [Time frame: Up to 3 years]
  • Disease Control Rate (DCR) [Time frame: Up to 3 years]

Eligibility criteria

Inclusion criteria

  • All individuals must have a tumor with protocol-specified mutation as determined by local health-authority approved test.
  • For Part A (including backfill cohorts): Individuals with histologically confirmed advanced or metastatic solid tumors who have progressed following treatment in the advanced or metastatic setting known to confer clinical benefit, unless the individual refused, is intolerant to, or is not eligible for standard-of-care (SOC) treatment.
  • For Part B dose expansion, individuals with protocol-specified tumor types will be enrolled.

Exclusion criteria

  • Use of any of the therapies listed below within the specified time frames:
  • Investigational drugs (drugs not marketed for any indication) within 28 days prior to Cycle 1 Day 1.
  • Anticancer biologic agent or immunotherapy within 28 days prior to Cycle 1 Day 1.
  • Anticancer chemotherapy or targeted approved small molecule therapy within 21 days prior to Cycle 1 Day 1, or 42 days for nitrosoureas or mitomycin.
  • Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started within 14 days prior to planned Cycle 1 Day 1 are not permitted. Exceptions: hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started at least 14 days prior to Cycle 1 Day 1.
  • Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal/biliary stent, biopsy) within 28 days prior to Cycle 1 Day 1, and any toxicity or complications have recovered to Grade 1 or less.
  • Radiation therapy within 21 days prior to Cycle 1 Day 1. Exception: limited (eg, pain palliation) radiation therapy is allowed if any radiation associated toxicity is resolved to Grade 1 or less, and the radiation is not administered to a target lesion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07703878 · GS-US-723-7652

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗