SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)

  • STATUS
    Recruiting
  • End date
    Jul 30, 2022
  • participants needed
    183
  • sponsor
    Scholar Rock, Inc.
Updated on 30 January 2021
lymphoma
measurable disease
EGFR
solid tumour
solid tumor
targeted therapy
solid neoplasm

Summary

This is 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 is divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).

Details
Condition Cancer, Cancer/Tumors, Ewing's Family Tumors, Cancer (Pediatric), Neoplasms, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors
Treatment SRK-181, anti-PD-(L)1 antibody therapy
Clinical Study IdentifierNCT04291079
SponsorScholar Rock, Inc.
Last Modified on30 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Cancer (Pediatric) or Cancer/Tumors or Cancer or Ewing's Family Tumors or Neoplasms?
Do you have any of these conditions: primary cancer or Ewing's Family Tumors or cancers or malignant tumors or malignant tumor or Neoplasms or Cancer (Pediatric) or Cancer or malignancies...?
Do you have any of these conditions: Cancer or Ewing's Family Tumors or primary malignant neoplasm or Cancer/Tumors or malignancies or malignant tumors or malignancy or primary cancer or ...?
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 and Part B
Patient must have a history of primary 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 an anti-PD-(L)1 antibody therapy (alone or in combination with chemotherapy) approved for that tumor type
Patient must have received their most recent dose of anti-PD-(L)1 antibody therapy within 6 months of enrollment
For NSCLC patients who have genomic tumor aberrations for which a targeted therapy is available (e.g., anaplastic lymphoma kinase, EGFR), these patients 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
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 pregnancy test within 72 hours prior to first administration of SRK-181 and a negative urine pregnancy test on the first day of dosing
WOCBP and males with female partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 90 days following the last dose of SRK-181

Exclusion Criteria

For Part A1 only
Patient has had anti-PD-(L)1 antibody therapy 28 days prior to enrollment
Patient is receiving concurrent anticancer treatment, including anti-PD-(L)1 antibody therapy, either approved or investigational, within 28 days prior to administration of SRK-181
For Part A2 and Part B only
Patient is receiving concurrent anticancer 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 administration 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 administration of SRK-181
Patient has received systemic cytotoxic chemotherapy (except for in combination with anti-PD-(L)1 antibody therapy) <28 days prior to administration of SRK-181
Patient has received targeted small molecule therapy within 5 half-lives of the compound prior to administration 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note