A Study of ASP3082 in Adults With Advanced Solid Tumors

Summary

This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D.

This study will be in 2 parts.

In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2.

In Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments.

Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.

Conditions

• Solid Tumor

Interventions

DRUG

Setidegrasib

Intravenous Infusion

DRUG

Cetuximab

Intravenous Infusion

DRUG

Leucovorin

Intravenous Infusion

DRUG

Oxaliplatin

Intravenous Infusion

DRUG

Fluorouracil

Intravenous Infusion

DRUG

Irinotecan

Intravenous Infusion

DRUG

Nanoparticle albumin-bound-paclitaxel

Intravenous Infusion

DRUG

Gemcitabine

Intravenous Infusion

DRUG

Docetaxel

Intravenous Infusion

DRUG

Pembrolizumab

Intravenous Infusion

DRUG

Cisplatin

Intravenous Infusion

DRUG

Carboplatin

Intravenous Infusion

DRUG

Pemetrexed

Intravenous Infusion

DRUG

Liposomal Irinotecan

Intravenous Infusion

Sponsors & Collaborators

• Astellas Pharma Inc

  lead INDUSTRY

Principal Investigators

• Medical Director · Astellas Pharma Inc

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-08

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States
• China
• France
• Japan
• Puerto Rico
• South Korea
• Spain

Study Locations