Sym024 and Sym021 for Solid Tumors

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by N. Lakhani, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Symphogen A/S

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to see if Sym024 is safe and tolerable as monotherapy and in combination with Sym021 in patients with solid tumor malignancies.

Eligibility Criteria

Adults with advanced solid tumors that can't be removed by surgery or have not responded to other treatments. Specific cancers include squamous cell carcinoma of the head and neck, pancreatic cancer, cholangiocarcinoma, colorectal cancer (MSS/MSI-H), gastric/esophageal/cervical carcinomas, non-small-cell lung carcinoma-adenocarcinoma subtype, and mesothelioma. Participants must have measurable disease, an ECOG performance status of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature, adequate organ function and agree to use contraception.

Inclusion Criteria

Measurable disease according to RECIST v1.1

I am 18 years old or older.

I have been diagnosed with cholangiocarcinoma.

Exclusion Criteria

I have a serious heart condition.

I have received radiotherapy with some exceptions.

I have had a serious gut problem in the last 6 months.

Participant Groups

The trial is testing Sym024 alone and combined with Sym021 for safety and tolerability in treating various types of solid tumor malignancies. The study will assess how patients' bodies react to these drugs when taken individually or together.

Group I: Sym024 Dose Level 4 Experimental Treatment 1 Intervention

Part I, Sym024 monotherapy dose level 4

Group II: Sym024 Dose Level 3 Experimental Treatment 1 Intervention

Part I, Sym024 monotherapy dose level 3

Group III: Sym024 Dose Level 2 Experimental Treatment 1 Intervention

Part I, Sym024 monotherapy dose level 2

Group IV: Sym024 Dose Level 1 Experimental Treatment 1 Intervention

Part I, Sym024 monotherapy dose level 1

Group V: Sym024 Dose Level -1 Experimental Treatment 1 Intervention

Part I, Sym024 monotherapy dose level -1. Evaluate only if needed based on tolerability

Group VI: Sym021+Sym024 Dose Level 5 Experimental Treatment 2 Interventions

Part IIa, Sym024 monotherapy and in combination with Sym021

Group VII: Sym021+Sym024 Dose Level 4 Experimental Treatment 2 Interventions

Part II, Sym021 in combination with dose level 4 of Sym024

Group VIII: Sym021+Sym024 Dose Level 3 Experimental Treatment 2 Interventions

Part II, Sym021 in combination with dose level 3 of Sym024

Group IX: Sym021+Sym024 Dose Level 2 Experimental Treatment 2 Interventions

Part II, Sym021 in combination with dose level 2 of Sym024

Group X: Sym021+Sym024 Dose Level 1 Experimental Treatment 2 Interventions

Part II, Sym021 in combination with dose level 1 of Sym024. Evaluate only if needed based on tolerability

Group XI: Dose Expansion Sym021 (+Sym024) Experimental Treatment 2 Interventions

Part III, dose expansion Sym024 and/or Sym021+Sym024

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MD Anderson Cancer Center Houston, TX

START Midwest Grand Rapids, MI

Princess Margaret Cancer Centre Toronto, Canada

NEXT Oncology San Antonio, TX

Who Is Running the Clinical Trial?

Symphogen A/S Lead Sponsor

References