SOT101 and Pembrolizumab for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Innovative Clinical Research Institute, Whittier, CAColorectal Cancer+5 MoreSOT101 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trialis testing a new drug to see if it can help fight cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Skin Squamous Cell Carcinoma
  • Liver Cancer
  • Castration-resistant Prostate Cancer
  • Ovarian Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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HFB301001
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HFB200301
1
GRT-C901

Study Objectives

1 Primary · 21 Secondary · Reporting Duration: Cycle 1 Day 1 to Cycle 3 Day 1 (up to approximately 9 weeks, where each cycle is 3 weeks)

Week 9
SOT101 Plasma Concentration Profile at Various Timepoints
Year 2
Number of Participants with Anti-drug Antibodies (ADAs)
mCRPC only: Circulating Tumor Cell (CTC) Count Conversion as Assessed According to PCWG3-modified RECIST 1.1
mCRPC only: Confirmed Prostate-specific Antigen (PSA) Decline of ≥50% as Assessed According to PCWG3-modified RECIST 1.1
mCRPC only: Time to Confirmed PSA Progression as Assessed According to PCWG3-modified RECIST 1.1
Year 3
Best Overall Response (BOR) According to RECIST 1.1
Clinical Benefit Rate (CBR) According to RECIST 1.1
Duration of Response (DoR) According to RECIST 1.1
Immune BOR (iBOR) According to iRECIST
Immune CBR (iCBR) According to iRECIST
Immune DoR (iDoR) According to iRECIST
Immune ORR (iORR) According to RECIST for immune-based therapeutics (iRECIST)
Immune PFS (iPFS) According to iRECIST
Immune TtR (iTtR) According to iRECIST
Metastatic Castration-resistant Prostate Cancer (mCRPC) only: DoR as Assessed According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3)-modified RECIST 1.1
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Number of Participants with an Adverse Event of Special Interest (AESI)
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
Progression-free Survival (PFS) According to RECIST 1.1
Time to Response (TtR) According to RECIST 1.1
mCRPC only: CBR as Assessed According to PCWG3-modified RECIST 1.1
mCRPC only: PFS as Assessed According to PCWG3-modified RECIST 1.1

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
HFB301001
1
HFB200301
2
GRT-C901

Trial Design

1 Treatment Group

SOT101 and Pembrolizumab
1 of 1

Experimental Treatment

320 Total Participants · 1 Treatment Group

Primary Treatment: SOT101 and Pembrolizumab · No Placebo Group · Phase 2

SOT101 and PembrolizumabExperimental Group · 2 Interventions: SOT101, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2200

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: cycle 1 day 1 to cycle 3 day 1 (up to approximately 9 weeks, where each cycle is 3 weeks)

Who is running the clinical trial?

SOTIO Biotech AGLead Sponsor
2 Previous Clinical Trials
264 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,707 Previous Clinical Trials
4,966,976 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have recovered from any side effects of previous treatments except for hair loss or have mild to moderate nerve damage.
References

Frequently Asked Questions

Is participation currently open for this trial?

"Affirmative. According to the clinicaltrials.gov records, this medical experiment was first advertised on June 21st 2022 and recently revised on January 5th 2023. The investigation is looking for 320 volunteers from a single trial site." - Anonymous Online Contributor

Unverified Answer

What is the current size of the participant pool in this experiment?

"Affirmative. According to the clinicaltrials.gov database, this clinical trial is actively recruiting individuals and was initially posted on June 21st 2022 before being recently amended on January 5th 2023. 320 participants are needed from a single medical facility." - Anonymous Online Contributor

Unverified Answer

What risks should be taken into consideration when administering SOT101 and Pembrolizumab?

"Considering the known safety data and lack of evidence on efficacy, our research team assigned SOT101 & pembrolizumab a score of 2." - 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.

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