A Study of ASP3082 in Adults With Advanced Solid Tumors

Conditions

• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Setidegrasib — DRUG
  Intravenous Infusion
• Cetuximab — DRUG
  Intravenous Infusion
• Leucovorin — DRUG
  Intravenous Infusion
• Oxaliplatin — DRUG
  Intravenous Infusion
• Fluorouracil — DRUG
  Intravenous Infusion
• Irinotecan — DRUG
  Intravenous Infusion
• Nanoparticle albumin-bound-paclitaxel — DRUG
  Intravenous Infusion
• Gemcitabine — DRUG
  Intravenous Infusion
• Docetaxel — DRUG
  Intravenous Infusion
• Pembrolizumab — DRUG
  Intravenous Infusion
• Cisplatin — DRUG
  Intravenous Infusion
• Carboplatin — DRUG
  Intravenous Infusion
• Pemetrexed — DRUG
  Intravenous Infusion
• Liposomal Irinotecan — DRUG
  Intravenous Infusion

Study Details

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.

Key Dates

Start date

Jun 8, 2022

Status verified

Apr 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

681 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: ASP3082 Dose Escalation (Monotherapy Part 1)
  Participants will receive ASP3082 in a 21-day cycle.
• Experimental: ASP3082 Dose Expansion (Monotherapy Part 2)
  Participants will receive ASP3082 with dose level(s) selected from dose escalation (part 1) in a 21-day cycle.
• Experimental: ASP3082 + Cetuximab Dose Escalation (Combination Therapy Part 1)
  Participants will receive ASP3082 in a 21-day cycle. Cetuximab will be administered weekly.
• Experimental: ASP3082 + Cetuximab Dose Expansion (Combination Therapy Part 2)
  Participants will receive ASP3082 or ASP3082 + Cetuximab with dose level(s) selected from dose escalation (part 1) in a 21-day cycle. Cetuximab will be administered weekly.
• Experimental: ASP3082 China Safety Cohort
  Participants will receive ASP3082 with dose level selected from dose escalation (Monotherapy part 1) in a 21-day cycle.
• Experimental: Treatment naive PDAC cohort ASP3082 + FOLFIRINOX
  Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with FOLFIRINOX (leucovorin \[LV\]/fluorouracil \[5-FU\]/irinotecan/oxaliplatin) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.
• Experimental: Treatment naive PDAC cohort ASP3082 + Nab-Paclitaxel + Gemcitabine
  Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with Nab-P + GEM (nanoparticle albumin-bound-paclitaxel plus gemcitabine) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.
• Experimental: ASP3082 + Docetaxel - NSCLC
  Participants with KRAS G12D mutant will receive ASP3082 in combination with docetaxel in a 21-day cycle.
• Experimental: ASP3082 + Pembrolizumab - NSCLC
  Participants with KRAS G12D mutant will receive ASP3082 in combination with pembrolizumab in a 21-day cycle.
• Experimental: ASP3082 + (Cisplatin or Carboplatin) and Pemetrexed +/- Pembrolizumab - NSCLC
  Participants with KRAS G12D mutant will receive ASP3082 in combination with platinum-based chemotherapy (cisplatin or carboplatin) and pemetrexed, with or without pembrolizumab in a 21-day cycle.
• Experimental: Treatment naive PDAC cohort ASP3082 + NALIRIFOX
  Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with NALIRIFOX (leucovorin\[LV\]/fluorouracil\[5-FU\]/liposomal irinotecan/oxaliplatin) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 Days ]

Central Contacts

• Astellas Pharma Global Development, Inc.
  800-888-7704
  [email protected]

Locations (23)

Find similar trials in Duarte, CA

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