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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Alterome Therapeutics, Inc.
Study ID
NCT06835569
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors
  • CRC (Colorectal Cancer)
  • Cancer
  • NSCLC (Non-small Cell Lung Cancer)
  • PDAC - Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Mar 5, 2025
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
448 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALTA3263 monotherapy
    ALTA3263 will be administered continuously at a protocol-defined dose based on cohort assignment
  • Experimental: ALTA3263 in combination with cetuximab
    ALTA3263 in combination with cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
  • Experimental: ALTA3263 in combination with mFOLFOX6 plus 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
  • Experimental: ALTA3263 in combination with pembrolizumab
    ALTA3263 in combination with pembrolizumab will be administered continuously at a protocol-defined dose based on cohort assignment
  • Experimental: ALTA3263 in combination with pembrolizumab plus chemotherapy
    ALTA3263 in combination with pembrolizumab, pemetrexed, and carboplatin/cisplatin will be administered continuously at a protocol-defined dose based on cohort assignment
  • Experimental: ALTA3263 in combination with mFOLFIRINOX
    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
  • Experimental: ALTA3263 in combination with mFOLFIRINOX plus cetuximab
    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
  • Experimental: ALTA3263 in combination with GnP
    ALTA3263 in combination with gemcitabine and albumin-bound paclitaxel will be administered continuously at a protocol-defined dose based on cohort assignment
  • Experimental: ALTA3263 in combination with GnP plus cetuximab
    ALTA3263 in combination with gemcitabine, albumin-bound paclitaxel plus cetuximab will be administered continuously at a protocol-defined dose based on cohort assignment
  • Experimental: ALTA3263 Midazolam DDI Substudy
    ALTA3263 and midazolam will be administered at a protocol defined schedule

Primary Outcome Measure

Adverse Events [ Time Frame: Up to 39 months ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Research SiteOrlandoFlorida32827-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02115-
Research SiteSt LouisMissouri63110-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10032-
Research SiteDurhamNorth Carolina27710-
Research SiteNashvilleTennessee37203-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78229-
Research Site #2San AntonioTexas78229-
Research SiteFairfaxVirginia22031-

Find similar trials in Orlando, FL

By research site
Research Site· Orlando, FLResearch Site· Boston, MAResearch Site· St Louis, MOResearch Site· New York, NYResearch Site· Durham, NCResearch Site· Nashville, TN

Related Studies