CancerPhase 1NCT04291079
SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)
A Phase 1 study testing SRK-181 and anti-PD-(L)1 antibody therapy in people with Cancer, run by Scholar Rock, Inc. at 22 sites in 2 countries.
Trial summary
This was a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- SRK-181 and anti-PD-(L)1 antibody therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 23 Apr 2020to 14 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a histologically documented solid tumor that is metastatic or locally advanced, for which SoC therapy does not exist, has failed in the patient, or is not tolerated by the patient, or for which the patient has been assessed by the Investigator as not being a suitable candidate or otherwise ineligible for the SoC therapy.
- For Part A2:
- o Patient must have a history of anti-PD-(L)1 antibody nonresponse presenting (based upon the Investigator's assessment) either as progressive disease or stable disease (e.g., not improving, but also not worsening, clinically or radiographically) after at least 3 cycles of treatment with the most recent anti-PD-(L)1 antibody therapy (alone or in combination with chemotherapy) approved for that tumor type. (Note: if the duration of prior anti-PD-1 therapy is shorter than 3 cycles and the reason for discontinuation is progressive disease, the progression should be associated with clinical deterioration.)
- For Part B Cohort NSCLC, UC, MEL and ccRCC:
- Patient must be diagnosed with one of the following disease-specific solid tumors of NSCLC, UC, or MEL, and must have a history of primary nonresponse to anti-PD-1 therapy (alone or in combination with other therapy), presenting the best response (based upon the Investigator's assessment) either as progressive disease or stable disease (e.g., not improving, but also not worsening, clinically or radiographically) after at least 3 cycles of treatment.
- For Cohort NSCLC, patients who have genomic tumor aberrations for which a targeted therapy is available (e.g., anaplastic lymphoma kinase, EGFR) must have progressed on an approved therapy for these aberrations or did not tolerate an approved therapy for these aberrations, or were not considered suitable candidates/ were otherwise ineligible for an approved therapy for these aberrations.
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- For Cohort ccRCC, patients must have a histologically confirmed diagnosis of RCC with a predominant clear cell component and must have received at least 1 prior line of anti-PD-1 treatment (alone or in combination with other therapy) and have had disease progression clinically or radiographically on the most recent anti-PD-1 treatment
- Up to 3 lines of treatment are allowed between the last dose of anti-PD-1 and enrollment.
- For Part B Cohort HNSCC:
- Patients must have a histologically confirmed diagnosis of recurrent or metastatic HNSCC that is non-amendable to curative therapy (e.g., radiation or surgery).
- The primary tumor location must be the oropharynx, oral cavity, hypopharynx, or larynx. Primary tumor site of nasopharynx (any histology) or unknown primary tumor are not eligible.
- Patients must have received one prior line of anti-PD-1 treatment (alone or in combination with other therapy) and have had disease progression clinically or radiographically on the anti-PD-1 treatment.
- Up to one line of treatment are allowed between the last dose of anti-PD-1 and enrollment.
- For patients with primary oropharyngeal cancer, patients must have results from testing of human papillomavirus (HPV) or P16 status.
- For Part B Cohort Any Other (enrollment complete): Patient must be diagnosed with any other solid tumor type that is not NSCLC, UC, MEL, or ccRCC for which the patient has had a history of primary anti PD (L)1 antibody nonresponse, presenting the best response (based upon the Investigator's assessment) as progressive disease, after prior anti-PD-(L)1 antibody therapy (alone or in combination with other therapy) currently approved for that tumor indication
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed at Screening.
- Patient must have an Eastern Cooperative Oncology Group performance status (PS) 0-1.
- Patient must have a predicted life expectancy of ≥ 3 months.
- Women of child-bearing potential (WOCBP) must have a negative urine or serum pregnancy test up to 24 hours prior to first dose of SRK-181.
- WOCBP and males with female partners of childbearing potential must agree to use adequate birth control throughout their participation and for 90 days following the last dose of SRK-181.
Who cannot join
- For Part A1 only:
- Patient has had anti-PD-(L)1 antibody therapy ≤ 28 days prior to the first dose of SRK-181.
- Patient is receiving concurrent anti-cancer treatment, including anti-PD-(L)1 antibody therapy, either approved or investigational, within 28 days prior to the first dose of SRK-181.
- For Part A2 and Part B only:
- Patient is receiving concurrent anti-cancer treatment, with the exception of an anti-PD-(L)1 antibody therapy for Part A2 or Part B, either approved or investigational, within 28 days prior to the first dose of SRK-181.
- Patient has received biologic therapy (except for anti-PD-(L)1 antibody therapy for Part A2 or Part B), <28 days prior to the first dose of SRK-181.
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- Patient has received systemic cytotoxic chemotherapy (except for in combination with anti-PD-(L)1 antibody therapy) <28 days prior to the first dose of SRK-181.
- Patient has received targeted small molecule therapy within 5 half-lives of the compound prior to the first dose of SRK-181.
- Patient has a history of intolerance or treatment discontinuation due to severe irAE or other adverse reaction from prior anti-PD-(L)1 antibody therapy.
- Patient has a hypersensitivity to anti-PD-(L)1 antibody therapy.
- Patient has the documented presence of neutralizing ADA to anti-PD-(L)1 antibody therapy.
- Patient has a diagnosis of immunodeficiency, either primary or acquired.
- Patient is symptomatic or has uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation.
- Patient has current second malignancy at other sites (exceptions: adequately treated in situ carcinoma [e.g., cervical], non-MEL skin cancer, bilateral synchronous discordant breast cancer, or indolent prostate cancer under observation). A past history of other malignancies is allowed as long as patient has been free of recurrence for ≥ 2 years, or if the patient has been treated with curative intent within the past 2 years and, in the opinion of the Investigator, is unlikely to have a recurrence.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States18 sites
University of Michigan
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02155
Advent Health
Celebration, Florida, 34747
University of Chicago
Chicago, Illinois, 60637
BUMC Mary Crowley Cancer Research Centers
Dallas, Texas, 75230
Henry Ford Cancer Institute
Detroit, Michigan, 48202
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, 46804
St. Jude Crosson Cancer Institute
Fullerton, California, 92835
Memorial Cancer Institute - South Broward Hospital District
Hollywood, Florida, 33021
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
University of California - San Diego
La Jolla, California, 92093
The Oncology Institute
Los Angeles, California, 90603
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Tennessee Oncology, Sarah Cannon Research Institute
Nashville, Tennessee, 37201
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Stony Brook University Cancer Center
Stony Brook, New York, 11794
H. Lee Moffitt Cancer Center& Research Institute
Tampa, Florida, 33612
South Korea4 sites
Korea University Ansan Hospital
Ansan-si, 92093
Seoul National University - Bundang Hospital
Seongnam-si, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation, and Dose-Expansion Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of SRK-181 Alone and in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)
This was a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study was divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).
- Conditions
- Cancer
- Being tested
- SRK-181, anti-PD-(L)1 antibody therapy
- Keywords
- Solid Tumor, Metastatic, Melanoma, Urothelial, Non-Small Cell Lung Carcinoma, ccRCC, Head and Neck Squamous Cell Carcinoma
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRK-181Biological
anti-latent TGFβ1 monoclonal antibody
anti-PD-(L)1 antibody therapyBiological
approved anti-PD-(L)1 antibody therapy for each tumor type
| Study group | Role | What they receive |
|---|---|---|
| Part A1: Dose Escalation | Experimental | Part A1 determined the maximum tolerated dose (MTD) or maximum administered dose (MAD) of SRK-181 as a single agent and the recommended Phase 2 dose (RP2D) of SRK-181 as a single-agent. Receives: Biological: SRK-181 |
| Part A2: Dose Escalation | Experimental | Part A2 determined the MTD or MAD of SRK-181 in combination with anti-PD-(L)1 antibody therapy and the RP2D of SRK-181 in combination with anti-PD-(L)1 antibody therapy for use in Part B. Receives: Biological: SRK-181; Biological: anti-PD-(L)1 antibody therapy |
| Part B: Dose Expansion | Experimental | In Part B, parallel cohorts of patients with Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), Cutaneous Melanoma (MEL), Clear Cell Renal Cell Carcinoma (ccRCC), Head and Neck Squamous Cell Carcinoma (HNSCC), or other advanced or metastatic solid tumor type that is not NSCLC, UC, MEL, or ccRCC were enrolled to confirm the tolerability of the RP2D of SRK-181 (determined in Part A2) and to evaluate the anti-tumor activity of SRK-181 in combination with an anti-PD-(L)1 antibody therapy. Receives: Biological: SRK-181; Biological: anti-PD-(L)1 antibody therapy |
| Long Term Extension Phase (LTEP) | Experimental | Patients may continue treatment in a LTEP:
* Part A1: Patients may continue treatment with SRK-181 as a single agent at the RP2D in the LTEP following 3 cycles of treatment with SRK-181 as a single agent in Part A1.
* Part A2: Patients may continue treatment with SRK-181 at the RP2D in combination with anti-PD-(L)1 antibody therapy in the LTEP following 3 cycles of treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy in Part A2.
* Part B: Patients may continue treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy following 9 cycles of treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy in Part B Receives: Biological: SRK-181; Biological: anti-PD-(L)1 antibody therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single agent SRK-181
Dose limiting toxicities (DLTs), as assessed by the Investigator, but not including toxicities clearly related to disease progression or intercurrent illness
Measured: The first 21 days of study treatment
Safety and tolerability of SRK-181 in combination with anti-PD-(L)1 antibody therapy
Dose limiting toxicities (DLTs), as assessed by the Investigator, but not including toxicities clearly related to disease progression or intercurrent illness
Measured: The first 21 days of study treatment
Secondary outcomes (6)
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Maximum drug concentration (Cmax)
Measured: Cycle 1 and Cycle 3 (each cycle is 21 days)
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Time to Cmax (Tmax)
Measured: Cycle 1 and Cycle 3 (each cycle is 21 days)
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Last validated plasma concentration (Clast)
Measured: Cycle 1 and Cycle 3 (each cycle is 21 days)
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Time to Clast (Tlast)
Measured: Cycle 1 and Cycle 3 (each cycle is 21 days)
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Half-life (t1/2)
Measured: Cycle 1 and Cycle 3 (each cycle is 21 days)
Anti-tumor activity of SRK-181, alone or in combination wit anti-PD-(L)1 antibody therapy as potential indicators of clinical response
Objective response, defined as a CR or PR, as determined by RECIST v1.1 or iRECIST v1.1
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start23 Apr 2020
- Primary completion14 Apr 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scholar Rock, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lu Gan, MD, Study director, Scholar Rock, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291079
- Sponsor's protocol ID
- SRK-181-001
- Status last verified
- Apr 2025
- First submitted
- 25 Feb 2020
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yap TA, Sweis RF, Vaishampayan U, Kilari D, Gainor JF, McKean M, Barve M, Tarhini AA, Bockorny B, Sonpavde G, Park D, Babu S, Ju Y, Liu L, Henry S, Tirucherai GS, DeWall S, Qatanani M, Marantz JL, Gan L. Linavonkibart and pembrolizumab in immune checkpoint blockade-resistant advanced solid tumors: a phase 1 trial. Nat Med. 2026 Mar;32(3):992-1001. doi: 10.1038/s41591-025-04157-w. Epub 2026 Jan 13.
PubMed 41530380
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation, and Dose-Expansion Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of SRK-181 Alone and in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)
- ClinicalTrials.gov ID
- NCT04291079
- Acronym / sponsor ID
- SRK-181-001
- Conditions
- Cancer
- Keywords
- Solid Tumor, Metastatic, Melanoma, Urothelial, Non-Small Cell Lung Carcinoma, ccRCC, Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Scholar Rock, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study was divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A1: Dose Escalation | Experimental | Biological: SRK-181Part A1 determined the maximum tolerated dose (MTD) or maximum administered dose (MAD) of SRK-181 as a single agent and the recommended Phase 2 dose (RP2D) of SRK-181 as a single-agent. |
| Part A2: Dose Escalation | Experimental | Biological: SRK-181, Biological: anti-PD-(L)1 antibody therapyPart A2 determined the MTD or MAD of SRK-181 in combination with anti-PD-(L)1 antibody therapy and the RP2D of SRK-181 in combination with anti-PD-(L)1 antibody therapy for use in Part B. |
| Part B: Dose Expansion | Experimental | Biological: SRK-181, Biological: anti-PD-(L)1 antibody therapyIn Part B, parallel cohorts of patients with Non-Small Cell Lung Cancer (NSCLC), Urothelial Carcinoma (UC), Cutaneous Melanoma (MEL), Clear Cell Renal Cell Carcinoma (ccRCC), Head and Neck Squamous Cell Carcinoma (HNSCC), or other advanced or metastatic solid tumor type that is not NSCLC, UC, MEL, or ccRCC were enrolled to confirm the tolerability of the RP2D of SRK-181 (determined in Part A2) and to evaluate the anti-tumor activity of SRK-181 in combination with an anti-PD-(L)1 antibody therapy. |
| Long Term Extension Phase (LTEP) | Experimental | Biological: SRK-181, Biological: anti-PD-(L)1 antibody therapyPatients may continue treatment in a LTEP: * Part A1: Patients may continue treatment with SRK-181 as a single agent at the RP2D in the LTEP following 3 cycles of treatment with SRK-181 as a single agent in Part A1. * Part A2: Patients may continue treatment with SRK-181 at the RP2D in combination with anti-PD-(L)1 antibody therapy in the LTEP following 3 cycles of treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy in Part A2. * Part B: Patients may continue treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy following 9 cycles of treatment with SRK-181 in combination with anti-PD-(L)1 antibody therapy in Part B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient has a histologically documented solid tumor that is metastatic or locally advanced, for which SoC therapy does not exist, has failed in the patient, or is not tolerated by the patient, or for which the patient has been assessed by the Investigator as not being a suitable candidate or otherwise ineligible for the SoC therapy.
- For Part A2:
- o Patient must have a history of anti-PD-(L)1 antibody nonresponse presenting (based upon the Investigator's assessment) either as progressive disease or stable disease (e.g., not improving, but also not worsening, clinically or radiographically) after at least 3 cycles of treatment with the most recent anti-PD-(L)1 antibody therapy (alone or in combination with chemotherapy) approved for that tumor type. (Note: if the duration of prior anti-PD-1 therapy is shorter than 3 cycles and the reason for discontinuation is progressive disease, the progression should be associated with clinical deterioration.)
- For Part B Cohort NSCLC, UC, MEL and ccRCC:
- For Part B Cohort HNSCC:
Key exclusion criteria (15 listed)
- For Part A1 only:
- For Part A2 and Part B only:
- Patient has a hypersensitivity to anti-PD-(L)1 antibody therapy.
- Patient has the documented presence of neutralizing ADA to anti-PD-(L)1 antibody therapy.
- Patient has a diagnosis of immunodeficiency, either primary or acquired.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRK-181anti-latent TGFβ1 monoclonal antibody | Biological | Long Term Extension Phase (LTEP), Part A1: Dose Escalation, Part A2: Dose Escalation, Part B: Dose Expansion |
| anti-PD-(L)1 antibody therapyapproved anti-PD-(L)1 antibody therapy for each tumor type | Biological | Long Term Extension Phase (LTEP), Part A2: Dose Escalation, Part B: Dose Expansion |
Primary outcome
Safety and tolerability of single agent SRK-181
Time frame: The first 21 days of study treatment
Dose limiting toxicities (DLTs), as assessed by the Investigator, but not including toxicities clearly related to disease progression or intercurrent illness
Safety and tolerability of SRK-181 in combination with anti-PD-(L)1 antibody therapy
Time frame: The first 21 days of study treatment
Dose limiting toxicities (DLTs), as assessed by the Investigator, but not including toxicities clearly related to disease progression or intercurrent illness
6 secondary outcomes
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Time frame: Cycle 1 and Cycle 3 (each cycle is 21 days)
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Time frame: Cycle 1 and Cycle 3 (each cycle is 21 days)
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Time frame: Cycle 1 and Cycle 3 (each cycle is 21 days)
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Time frame: Cycle 1 and Cycle 3 (each cycle is 21 days)
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Time frame: Cycle 1 and Cycle 3 (each cycle is 21 days)
Anti-tumor activity of SRK-181, alone or in combination wit anti-PD-(L)1 antibody therapy as potential indicators of clinical response
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 41530380Yap TA, Sweis RF, Vaishampayan U, Kilari D, Gainor JF, McKean M, Barve M, Tarhini AA, Bockorny B, Sonpavde G, Park D, Babu S, Ju Y, Liu L, Henry S, Tirucherai GS, DeWall S, Qatanani M, Marantz JL, Gan L. Linavonkibart and pembrolizumab in immune checkpoint blockade-resistant advanced solid tumors: a phase 1 trial. Nat Med. 2026 Mar;32(3):992-1001. doi: 10.1038/s41591-025-04157-w. Epub 2026 Jan 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Gan, MD study director
Scholar Rock, Inc.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SRK-181 and anti-PD-(L)1 antibody therapy in people with Cancer, run by Scholar Rock, Inc. at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of single agent SRK-181 (time frame: The first 21 days of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04291079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.