SD-101 for Pancreatic Cancer

MD Anderson Cancer Center, Houston, TX
Pancreatic CancerSD-101 - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new treatment for advanced pancreatic cancer using injections and drugs to boost the immune system.

Eligible Conditions
  • Pancreatic Cancer Locally Advanced

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 12 months

12 months
Phase 1 - To assess the RECIST v1.1 ORR
Phase 1 - To determine the maximum tolerated dose (MTD) of SD-101 administered alone via PRVI.
Pancreas
Phase 1b - To assess preliminary efficacy in terms of RECIST for immune based therapeutics on ORR.
Phase 1b - To assess preliminary efficacy in terms of RECIST for immune based therapeutics on clinical benefit ([CR] + [PR] + [SD]).
Phase 1b - To assess preliminary efficacy in terms of RECIST for immune based therapeutics on duration of response.
Phase 1b - To assess progression-free survival (PFS) of PRVI of SD-101 in combination with intravenous (IV) immunological checkpoint blockade.
Phase 1b - To assess the 12-month overall survival (OS) of PRVI of SD-101 in combination with intravenous (IV) immunological checkpoint blockade.
Phase 1b - To determine the safety of SD-101 administered via PRVI in combination with pembrolizumab and to assess the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 overall response rate (ORR)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

SD-101
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: SD-101 · No Placebo Group · Phase 1

SD-101Experimental Group · 2 Interventions: SD-101, pebrolizumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SD-101
2014
Completed Phase 2
~90

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

TriSalus Life Sciences, Inc.Lead Sponsor
2 Previous Clinical Trials
169 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

What is the upper limit of patients engaged in this medical experiment?

"Confirmed. Evidence available on clinicaltrials.gov demonstrates that this experiment, which was first advertised on the 1st of November 2022, is still in its recruitment phase. The endeavour requires 60 participants from a single centre to be enrolled." - Anonymous Online Contributor

Unverified Answer

Are new participants being sought for this trial at the present time?

"According to clinicaltrials.gov, this medical trial is open for recruitment with the first advertisement posted on November 1st 2022 and updated as recently as November 18th of the same year." - Anonymous Online Contributor

Unverified Answer

Is SD-101 a reliable form of treatment for patients?

"Available evidence on SD-101's safety is somewhat scant, prompting our team at Power to assign it a score of 1. This early phase trial provides limited data regarding its efficacy and security." - Anonymous Online Contributor

Unverified Answer

What goals is this clinical experiment attempting to accomplish?

"The main purpose of the clinical trial, which will span 12 months, is to ascertain the maximum tolerated dose (MTD) for SD-101 administered via PRVI. Secondary objectives include assessing overall survival over a one year period and RECIST v1.1 ORR as measures of activity, coupled with determining preliminary efficacy in terms of RECIST for immune based therapeutics on clinical benefit ([CR] + [PR] + [SD])." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.