Active — Not RecruitingPhase 1/2

A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors

United States125 participantsStarted 2020-10-07

Plain-language summary

Part 1: A first-in-human, open-label, Phase I dose escalation study of DSP107 monotherapy and combination therapy with atezolizumab in patients with advanced solid tumors. Part 2: Preliminary efficacy assessment of DSP107 in combination with atezolizumab in second or third line treatment of non small cell lung cancer. Preliminary efficacy assessment of DSP107 as a single agent or in combination with atezolizumab in third line treatment of colorectal cancer.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Subject must have measurable disease per RECIST version 1.1 * Part 1: o Histologically confirmed advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit or subject is intolerant or has refused available therapies * Part 2, Expansion Cohort A: * Histologically confirmed, inoperable non-small cell lung cancer (Stage 3b or Stage 4). Squamous and non-squamous histologies are both acceptable * Wildtype for actionable oncogenic driver mutations (e.g., ALK, EGFR, ROS1, RET, NTRK). Driver mutations for KRAS, BRAF and c-METex14skip will be allowed. * Received no more than 2 lines of prior systemic treatment, including anti PD-1 or anti PD-L1 therapeutic agent ± chemotherapy. Targeted therapies for KRAS, BRAF and c-METex14skip will not be counted towards the previous lines of therapy. * Part 2, Expansion Cohort B: * Histologically confirmed, inoperable microsatellite stable colorectal carcinoma (Stage 3b or Stage 4) * Received two previous lines of therapy including standard chemotherapy and/or targeted antibodies Exclusion Criteria: * Life expectancy of ≤ 3 months * Central nervous system (CNS) metastases * Life-threatening (grade 4) immune-mediated adverse event related to prior immunotherapy * Immune-mediated adverse reaction that required discontinuation of prior immunotherapy * Past or…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Events (AEs)

Timeframe: Duration of the study, estimated to be 9 months

Dose Limiting Toxicities (DLT)

Timeframe: At the end of Treatment Cycle 1 (each cycle is 21 days)

DSP107 Serum Concentration

Timeframe: At the end of Treatment Cycle 8 (each cycle is 21 days)

Trial details

NCT IDNCT04440735

SponsorKahr Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09

View on ClinicalTrials.gov More Advanced Solid Tumor trials