A Phase 1 interventional study of ALTA3263 and cetuximab in Cancer, PDAC - Pancreatic Ductal Adenocarcinoma and NSCLC (Non-small Cell Lung Cancer), sponsored by Alterome Therapeutics, Inc.. Recruiting at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Alterome Therapeutics, Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 448 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Alterome Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other inclusion/exclusion criteria may apply.
ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263
ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263 · Drug: cetuximab
ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, and oxaliplatin (mFOLFOX6) and cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263 · Drug: cetuximab · Drug: mFOLFOX6
ALTA3263 in combination with pembrolizumab will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263 · Drug: Pembrolizumab
ALTA3263 in combination with pembrolizumab, pemetrexed, and carboplatin/cisplatin will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263 · Drug: Pembrolizumab · Drug: Pemetrexed + Cisplatin /Carboplatin
ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263 · Drug: mFOLFIRINOX
ALTA3263 in combination with modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263 · Drug: cetuximab · Drug: mFOLFIRINOX
ALTA3263 in combination with gemcitabine and albumin-bound paclitaxel will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263 · Drug: GnP
ALTA3263 in combination with gemcitabine, albumin-bound paclitaxel plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
Drug: ALTA3263 · Drug: cetuximab · Drug: GnP
ALTA3263 and midazolam will be administered at a protocol defined schedule
Drug: ALTA3263 · Drug: Midazolam
Oral ALTA3263 tablets will be administered at a protocol-defined dose
Cetuximab injection for IV use will be administered at a protocol-defined dose
modified folinic acid (leucovorin), fluorouracil, and oxaliplatin will be administered at a protocol-defined dose
Pembrolizumab injection for IV use will be administered at a protocol-defined dose
Pemetrexed and carboplatin/cisplatin injection for IV use will be administered at a protocol-defined dose
modified folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin will be administered at a protocol-defined dose
gemcitabine and albumin-bound paclitaxel will be administered at a protocol-defined dose
Oral midazolam will be administered at a protocol-defined dose
Adverse Events
Number of participants that experience treatment-emergent adverse events (TEAEs).
Time frame: Up to 39 months
Dose Limiting Toxicities
Number of participants with Dose Limiting Toxicities (DLTs).
Time frame: 21 days
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
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
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
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
Objective Response Rate (ORR)
Assess per RECIST 1.1
Time frame: Up to 39 months
Duration of Response (DOR)
Assess per RECIST 1.1
Time frame: Up to 39 months
Progression-Free Survival (PFS)
Assess per RECIST 1.1
Time frame: Up to 39 months
Overall Survival (OS)
Assess per RECIST 1.1
Time frame: Up to 39 months
Plan to share: No
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Alterome Therapeutics, Inc.