NCT04190628

Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors

Terminated Phase 1 Last updated 21 May 2024

What this trial tests

Phase 1 trial testing ABM-1310 in Advanced Solid Tumor in 53 participants. Terminated before completion.

Timeline

16 June 2020

Primary endpoint
5 April 2024

5 April 2024

Quick facts

Lead sponsor	ABM Therapeutics Corporation
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	16 June 2020
Primary completion	5 April 2024
Estimated completion	5 April 2024
Sites	8 locations across United States

Drugs / interventions tested

• ABM-1310 — full drug profile →
• Cobimetinib (cobimetinib) — full drug profile →

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
• BRAF V600 Mutation — all drugs for BRAF V600 Mutation →

Sponsor

ABM Therapeutics Corporation — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor or BRAF V600 Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I, First-In-Human, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in adult patients with locally advanced or metastatic solid tumors who have no effective standard treatment options available, as monotherapy in patients with documented BRAF V600 mutation, or in combination with cobimetinib (Cotellic®) in adult patients who have documented BRAF mutation and progressive disease or intolerance to at least one prior line of systemic therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the RAS/RAF/MAPK pathway for cancer therapy: from mechanism to clinical studies.
   Bahar ME, Kim HJ, Kim DR. · · 2023 · cited 519× · PMID 38105263 · DOI 10.1038/s41392-023-01705-z
2. Targeted therapy in advanced non-small cell lung cancer: current advances and future trends.
   Majeed U, Manochakian R, Zhao Y, Lou Y. · · 2021 · cited 193× · PMID 34238332 · DOI 10.1186/s13045-021-01121-2
3. Brain metastases: A Society for Neuro-Oncology (SNO) consensus review on current management and future directions.
   Aizer AA, Lamba N, Ahluwalia MS, Aldape K, et al · · 2022 · cited 116× · PMID 35762249 · DOI 10.1093/neuonc/noac118
4. The Evolutionary Landscape of Treatment for <i>BRAF^V600E</i> Mutant Metastatic Colorectal Cancer.
   Mauri G, Bonazzina E, Amatu A, Tosi F, et al · · 2021 · cited 53× · PMID 33406649 · DOI 10.3390/cancers13010137
5. Targeting BRAF pathway in low-grade serous ovarian cancer.
   Perrone C, Angioli R, Luvero D, Giannini A, et al · · 2024 · cited 44× · PMID 38768941 · DOI 10.3802/jgo.2024.35.e104
6. Update on the Management of Brain Metastasis.
   Singh K, Saxena S, Khosla AA, McDermott MW, et al · · 2022 · cited 38× · PMID 36422836 · DOI 10.1007/s13311-022-01312-w
7. Novel Inhibitor-Based Therapies for Thyroid Cancer-An Update.
   Ratajczak M, Gaweł D, Godlewska M. · · 2021 · cited 37× · PMID 34769260 · DOI 10.3390/ijms222111829
8. Changing Landscape of Systemic Therapy in Biliary Tract Cancer.
   Woods E, Le D, Jakka BK, Manne A. · · 2022 · cited 31× · PMID 35565266 · DOI 10.3390/cancers14092137