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

ConditionsCancerPDAC - Pancreatic Ductal AdenocarcinomaNSCLC (Non-small Cell Lung Cancer)CRC (Colorectal Cancer)Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlterome Therapeutics, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALTA3263

    Drug

    Oral ALTA3263 tablets will be administered at a protocol-defined dose

  • cetuximab

    Drug

    Cetuximab injection for IV use will be administered at a protocol-defined dose

  • mFOLFOX6

    Drug

    modified folinic acid (leucovorin), fluorouracil, and oxaliplatin will be administered at a protocol-defined dose

  • Pembrolizumab

    Drug

    Pembrolizumab injection for IV use will be administered at a protocol-defined dose

  • Pemetrexed + Cisplatin /Carboplatin

    Drug

    Pemetrexed and carboplatin/cisplatin injection for IV use will be administered at a protocol-defined dose

  • mFOLFIRINOX

    Drug

    modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose

  • GnP

    Drug

    gemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose

  • Midazolam

    Drug

    Oral midazolam will be administered at a protocol-defined dose

Treatment groups

448 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: ALTA3263 monotherapyExperimental treatment 1 intervention
Group B: ALTA3263 in combination with cetuximabExperimental treatment 2 interventions
Group C: ALTA3263 in combination with mFOLFOX6 plus cetuximabExperimental treatment 3 interventions
Group D: ALTA3263 in combination with pembrolizumabExperimental treatment 2 interventions
Group E: ALTA3263 in combination with pembrolizumab plus chemotherapyExperimental treatment 3 interventions
Group F: ALTA3263 in combination with mFOLFIRINOXExperimental treatment 2 interventions
Group G: ALTA3263 in combination with mFOLFIRINOX plus cetuximabExperimental treatment 3 interventions
Group H: ALTA3263 in combination with GnPExperimental treatment 2 interventions
Group I: ALTA3263 in combination with GnP plus cetuximabExperimental treatment 3 interventions
Group J: ALTA3263 Midazolam DDI SubstudyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adverse Events

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

Time frame
Up to 39 months
2

Dose Limiting Toxicities

Number of participants with Dose Limiting Toxicities (DLTs).

Time frame
21 days

Secondary outcomes

1

Maximum Observed Plasma Concentration (Cmax)

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
2

Time to Reach Maximum Observed Plasma Concentration (Tmax)

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
3

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

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
4

Terminal Half-Life (t1/2)

t1/2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alterome Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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