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

NCT06835569
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
448
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Lead sponsor
Alterome Therapeutics, Inc.
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Start date
2025-03-05
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Number of sites
12
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Summary
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
clinicaltrials.gov
Short title
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
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Official title
A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-08-01
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First posted
2025-02-19
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Registry last updated
2026-06-10
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Primary completion date
2029-05-01
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Start date
2025-03-05
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Participants
448
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Participant count basis
Estimated
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Planned participants
448
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Protocol amendments
3
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Number of sites
12
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Alterome Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06835569
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ClinicalTrials.gov ID
NCT06835569
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Adverse Events

    Timeframe: Up to 39 months

    Number of participants that experience treatment-emergent adverse events (TEAEs).

  2. Dose Limiting Toxicities

    Timeframe: 21 days

    Number of participants with Dose Limiting Toxicities (DLTs).

  1. Maximum Observed Plasma Concentration (Cmax)

    Timeframe: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose

    Cmax

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Timeframe: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose

    Tmax

  3. Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)

    Timeframe: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 15: Predose and up to 24 hours postdose

    AUCt

  4. Terminal Half-Life (t1/2)

    Timeframe: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 48 hours postdose

    t1/2

  5. Objective Response Rate (ORR)

    Timeframe: Up to 39 months

    Assess per RECIST 1.1

  6. Duration of Response (DOR)

    Timeframe: Up to 39 months

    Assess per RECIST 1.1

  7. Progression-Free Survival (PFS)

    Timeframe: Up to 39 months

    Assess per RECIST 1.1

  8. Overall Survival (OS)

    Timeframe: Up to 39 months

    Assess per RECIST 1.1

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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.

Sources for eligibility
clinicaltrials.gov

  • Research SiteOrlando, United StatesRecruiting
  • Research SiteBoston, United StatesRecruiting
  • Research SiteBoston, United StatesRecruiting
  • Research SiteSt Louis, United StatesRecruiting
  • Research SiteNew York, United StatesRecruiting
  • Research SiteNew York, United StatesRecruiting
  • Research SiteDurham, United StatesRecruiting
  • Research SiteNashville, United StatesRecruiting
  • Research SiteHouston, United StatesRecruiting
  • Research Site #2San Antonio, United StatesRecruiting
  • Research SiteSan Antonio, United StatesRecruiting
  • Research SiteFairfax, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (7)

Lead sponsors (1)

Conditions (7)

Targets (21)