SLC-0111 + Gemcitabine for Pancreatic Cancer

(SLC-0111-17-01 Trial)

Recruiting at1 trial location

Overseen by Daniel J Renouf, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: British Columbia Cancer Agency

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a multi-center, open-label Phase 1b study of SLC-0111 (oral) in combination with IV gemcitabine in CA IX positive subjects with mPDAC and comprises of 2 parts: * Part 1: Dose Escalation * Part 2: Dose Expansion

Research Team

Daniel J Renouf, MD

Principal Investigator

BC Cancer - Vancouver

Eligibility Criteria

This trial is for adults over 18 with metastatic pancreatic ductal adenocarcinoma that's spread beyond the pancreas but not to local lymph nodes. Participants must have tumors positive for CAIX, be able to give a biopsy if no old tissue samples exist, and have an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but can do light work.

Inclusion Criteria

Able and willing to provide written pre-screening informed consent and to comply with the study protocol and procedures

I am willing to provide a biopsy if no old cancer tissue samples exist.

Life expectancy greater than 3 months in the investigator's opinion

Exclusion Criteria

I am not pregnant, planning to become pregnant, or breastfeeding.

I have severe heart problems that needed hospital care recently or limit my activities.

Hypersensitivity to investigational products or their excipients or severe allergy to sulfonamides

Treatment Details

Interventions

• Gemcitabine Injection (Anti-metabolites)
• SLC-0111 (Other)

Trial Overview The study tests SLC-0111 taken orally alongside IV gemcitabine injections in two parts: first finding the right dose (Dose Escalation) and then giving this dose to more people (Dose Expansion). It aims to see how well these drugs work together against advanced pancreatic cancer.

Participant Groups

Group I: SLC-0111 + Gemcitabine Experimental Treatment 2 Interventions

Dose Level 1 - SLC-0111 (500 mg/day PO daily for 28 days) and Gemcitabine (1000 mg/m\^2 IV on day 1, 8, and 15) Dose Level 2 - SLC-0111 (750 mg/day PO daily for 28 days) and Gemcitabine (1000 mg/m\^2 IV on day 1, 8, and 15) Dose Level 3 - SLC-0111 (1000 mg/day PO daily for 28 days) and Gemcitabine (1000 mg/m\^2 IV on day 1, 8, and 15)

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Dr. Kim Nguyen Chi

British Columbia Cancer Agency

Chief Executive Officer since 2023

MD

Dr. Kim Nguyen Chi

British Columbia Cancer Agency

Chief Medical Officer since 2023

MD

Welichem Biotech Inc.

Industry Sponsor

Trials

6

Recruited

310+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

SignalChem Lifesciences Corporation

Industry Sponsor

Trials

4

Recruited

160+