Trial · NCT04787042
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
NCT04787042, Phase 1, Phase 2, Recruiting, Simcha IL-18, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067. Trials, record NCT04787042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04787042
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
- NCT number
- NCT04787042
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 316 participants, estimated
- Lead sponsor
- Simcha IL-18, Inc.
- Conditions
- Cancer, Solid Tumor, Melanoma, Renal Cell Carcinoma, Triple-negative Breast Cancer, Non Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Carcinoma, MSI-High
- Interventions
- ST-067, Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA], pembrolizumab
- First posted
- 2021-03-08
- Last updated
- 2024-11-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the maximum tolerated dose of ST-067 in phase 1a monotherapy | Day 29 | Patients will be enrolled at a dose level that is predicted to be the MTD |
| Primary | Evaluate the overall safety and tolerability of ST-067 in combination with pembrolizumab | Day 29 | In patients experiencing insufficient response to a checkpoint inhibitor (PD-1) therapy administered alone or in combination. |
| Primary | Number of Participants With Treatment-Related Adverse Events | Day 29 | AE assessed by CTCAE 5.0 |
| Primary | Initial assessment of efficacy in phase 2 | At 8 weeks | Investigator-assessed ORR, defined as either a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on computed tomography (CT) or magnetic resonance imaging (MRI) scans |
| Secondary | PK | Day 29 | Peak Plasma Concentration (Cmax) |
| Secondary | ADA | Day 29 | Incidence of ADA to ST-067 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04787042
GET https://conductscience.org/api/trials/v1/NCT04787042/registered