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Recruiting NCT06835569

A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

Phase I Interventional Cancer PDAC - Pancreatic Ductal Adenocarcinoma NSCLC (Non-small Cell Lung Cancer) CRC (Colorectal Cancer)

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: ALTA3263, cetuximab, mFOLFOX6, Pembrolizumab.
Who it may be relevant to
Registry conditions: Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC (Non-small Cell Lung Cancer), CRC (Colorectal Cancer). 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
United States
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 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations

Overview

The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.

Detailed description

This is an open-label, multicenter, Phase 1/1b study of ALTA3263, an orally bioavailable KRAS isoform-selective inhibitor that inhibits multiple mutant forms of KRAS, in adults with advanced solid tumor malignancies with KRAS mutations. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA3263 as a monotherapy and as a combination regimen. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.

Interventions

  • Drug ALTA3263
    Oral ALTA3263 tablets will be administered at a protocol-defined dose
  • Drug cetuximab
    Cetuximab injection for IV use will be administered at a protocol-defined dose
  • Drug mFOLFOX6
    modified folinic acid (leucovorin), fluorouracil, and oxaliplatin will be administered at a protocol-defined dose
  • Drug Pembrolizumab
    Pembrolizumab injection for IV use will be administered at a protocol-defined dose
  • Drug Pemetrexed + Cisplatin /Carboplatin
    Pemetrexed and carboplatin/cisplatin injection for IV use will be administered at a protocol-defined dose
  • Drug mFOLFIRINOX
    modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose
  • Drug GnP
    gemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose
  • Drug Midazolam
    Oral midazolam will be administered at a protocol-defined dose

Primary outcome measures

  • Adverse Events [Time frame: Up to 39 months]
  • Dose Limiting Toxicities [Time frame: 21 days]
Secondary outcome measures (8)
  • Maximum Observed Plasma Concentration (Cmax) [Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose]
  • Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt) [Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose]
  • Terminal Half-Life (t1/2) [Time frame: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose]
  • Objective Response Rate (ORR) [Time frame: Up to 39 months]
  • Duration of Response (DOR) [Time frame: Up to 39 months]
  • Progression-Free Survival (PFS) [Time frame: Up to 39 months]
  • Overall Survival (OS) [Time frame: Up to 39 months]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
  • Unresectable or metastatic disease.
  • Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function

Exclusion criteria

  • Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol
  • Known condition that prohibits the ability to swallow or absorb an oral medication.

Other 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
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Research Site — Orlando
  • Research Site — Boston
  • Research Site — Boston
  • Research Site — St Louis
  • Research Site — New York
  • Research Site — New York
  • Research Site — Durham
  • Research Site — Nashville
  • … and 4 more centers

Identifiers

NCT: NCT06835569 · 3263-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗