A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

Conditions

• BRAF V600 Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dabrafenib — DRUG
  Capsule for oral use
• LTT462 — DRUG
  Capsule for oral use
• Trametinib — DRUG
  Tablet for oral use
• LXH254 — DRUG
  Tablet for oral use
• TNO155 — DRUG
  Capsule for oral use
• Spartalizumab — BIOLOGICAL
  Liquid in vial (Concentrate for solution for infusion) for intravenous use
• Tislelizumab — BIOLOGICAL
  Liquid in vial (Concentrate for solution for infusion) for intravenous use

Study Details

A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.

Key Dates

Start date

Jul 22, 2020

Status verified

Dec 2025

Primary completion

Sep 25, 2024

Completion

Sep 25, 2024

Study Design

Enrollment

122 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dabrafenib + LTT462 backbone arm 1
  dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
• Experimental: Dabrafenib + LTT462 + trametinib triplet arm 1
  dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
• Experimental: Dabrafenib + LTT462 + LXH254 triplet arm 2
  dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment.
• Experimental: Dabrafenib + LTT462 + TNO155 triplet arm 3
  dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
• Experimental: Dabrafenib + LTT462 + spartalizumab triplet arm 4
  dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer - Arm is closed for further enrollment.
• Experimental: Dabrafenib + trametinib + TNO155 triplet arm 5
  dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer
• Experimental: Dabrafenib + LTT462 + Tislelizumab triplet arm 6
  dose escalation to determine maximum tolerated dose (MTD)/ Recommended dose (RD) in adult patients with advanced or metastatic BRAF V600 colorectal cancer

Primary Outcome Measure

Incidence and nature of dose limiting toxicities (DLTs) in the first cycle [ Time Frame: 30 months ]

Locations (4)

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