A Study to Assess the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 in Adults With Locally Advanced or Metastatic Solid Tumours (NCT07213817)
An Open-Label, Phase I/II First-in-Human, Dose Escalation, Dose Optimisation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 as Single Agent in Adult Participants With Locally Advanced or Metastatic Solid Tumours.
🩺 Plain-English Summary (8th-Grade Level)
This study aims to find the right dosage and evaluate the safety and effectiveness of the drug IPN60300 in adults with advanced solid tumours, which are cancers that have spread to other parts of the body from their original location. All participants will receive the drug by injection. Study Phases: * Phase Ia: Participants with certain types of tumours will be treated in cohorts of increasingly higher doses of the drug to determine the safe and effective dose range (a high and a low dose). * Phase Ib: Participants with a specific tumour type will receive one of the two doses identified in phase Ia. The dose level will be assigned randomly (by chance). Study Periods: Screening: Up to 28 days before first IPN60300 injection to determine eligibility. Treatment: Starts with the first dose of IPN60300 and continues until it needs to be stopped due to harmful effects, the disease getting worse, or if the participant decides to stop taking part in the study, the investigator's decision to stop treatment, death or the study is terminated early by the sponsor. Participants will undergo blood tests, urine collections, physical examinations, and clinical evaluations.
Who can join: Review the eligibility criteria below.
Location: Yale Cancer Center-Yale University — New Haven, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- Yale Cancer Center-Yale University — New Haven, Connecticut
- START Midwest — Grand Rapids, Michigan
- Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania
- MD Anderson Cancer Center — Houston, Texas
- NEXT Oncology — San Antonio, Texas
- NEXT Oncology — Fairfax, Virginia
- Centre Leon Berard — Lyon,
- Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau — Saint-Herblain,
- Gustave Roussy Cancer Campus Grand Paris- (Institut de Cancerologie Gustave-Roussy) — Villejuif,
- Hospital Universitari Vall d'Hebron — Barcelona,
- NEXT Quiron-Barcelona — Barcelona,
- START Madrid CIOCC Hospital Universitario HM Sanchinarro — Madrid,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Locally Advanced Solid Tumor
- A First-in-Human, Phase 1 Study of TST003 in Subjects With Solid Tumors — Portland, Oregon
- ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR) — San Diego, California
- A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1) — Orange, California
- Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors — Palo Alto, California
- A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1) — Irvine, California
Explore by condition: All Locally Advanced Solid Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.