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Monoclonal Antibodies
SRK-181 + Anti-PD-(L)1 for Cancer
Phase 1
Waitlist Available
Research Sponsored by Scholar Rock, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have an Eastern Cooperative Oncology Group performance status (PS) 0-1.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new drug, SRK-181, to see if it is safe and effective in treating solid tumors. The study will test different doses of the drug alone and in combination with another anti-cancer drug. The trial is divided into 3 parts, with a long-term extension phase.
Who is the study for?
This trial is for adults with advanced solid tumors who haven't responded to anti-PD-(L)1 therapy, have measurable disease, and no suitable standard care options. They must be in good physical condition with a life expectancy of at least 3 months. Women must test negative for pregnancy and agree to birth control measures.Check my eligibility
What is being tested?
The DRAGON study tests SRK-181 alone or combined with anti-PD-(L)1 therapy in patients whose cancer hasn't improved after previous treatments. It's an early-phase trial assessing safety, dosage, body response, and effectiveness across multiple patient groups.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs due to the drug's mechanism of enhancing immune activity against cancer cells. Specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can carry out all my usual activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of SRK-181 in combination with anti-PD-(L)1 antibody therapy
Safety and tolerability of single agent SRK-181
Secondary outcome measures
Anti-tumor activity of SRK-181, alone or in combination wit anti-PD-(L)1 antibody therapy as potential indicators of clinical response
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Side effects data
From 2021 Phase 2 trial • 22 Patients • NCT03019640100%
Lymphocyte count decreased
100%
White blood cell decreased
100%
Nausea
100%
Fever
100%
Platelet count decreased
100%
Anemia
100%
Neutrophil count decreased
95%
Diarrhea
82%
Hyperglycemia
77%
Mucositis oral
77%
Fatigue
64%
Sinus tachycardia
59%
Hypotension
59%
Anorexia
55%
Hypophosphatemia
55%
Constipation
55%
Edema limbs
55%
Rash maculo-papular
50%
Headache
45%
Hypoalbuminemia
45%
Hypocalcemia
45%
Alanine aminotransferase increased
41%
Hypokalemia
41%
Dizziness
36%
Hyponatremia
36%
Anxiety
32%
Investigations
32%
Insomnia
32%
Vomiting
32%
Chills
32%
Cough
32%
Febrile neutropenia
32%
Hypertension
27%
Pain
27%
Alkaline phosphatase increased
27%
Aspartate aminotransferase increased
23%
Hypomagnesemia
23%
Infections and infestations
23%
Dysphagia
23%
Arthralgia
23%
Esophagitis
23%
Hiccups
18%
Dehydration
18%
Hypoxia
18%
Abdominal pain
18%
Allergic rhinitis
18%
Dyspnea
18%
Generalized muscle weakness
18%
Hemorrhoids
14%
Infusion related reaction
14%
INR increased
14%
Immune system disorders
14%
Bloating
14%
Paresthesia
14%
Pleural effusion
14%
Dyspepsia
14%
Hypermagnesemia
14%
Rectal pain
9%
Upper respiratory infection
9%
Sore throat
9%
Blood bilirubin increased
9%
Bone pain
9%
Cholesterol high
9%
Creatinine increased
9%
Nasal congestion
9%
Papulopustular rash
9%
Arthritis
9%
Back pain
9%
Dry skin
9%
Dysgeusia
9%
Flushing
9%
General disorders and administration site conditions
9%
Hypernatremia
9%
Hyperuricemia
9%
Non-cardiac chest pain
9%
Renal and urinary disorders
9%
Skin ulceration
5%
Hypoglycemia
5%
Lymph node pain
5%
Tremor
5%
Hypothyroidism
5%
Lung infection
5%
Thromboembolic event
5%
Urinary tract pain
5%
Vascular disorders
5%
Weight gain
5%
Lymphocyte count increased
5%
Myalgia
5%
Urinary tract infection
5%
Urinary frequency
5%
Lung
5%
Eye disorders
5%
Gastroesophageal reflux disease
5%
Mucosal infection
5%
Metabolism and nutrition disorders
5%
Musculoskeletal and connective tissue disorder
5%
Peripheral motor neuropathy
5%
Prostatic obstruction
5%
Pulmonary edema
5%
Rash acneiform
5%
Respiratory failure
5%
Acute kidney injury
5%
Ear pain
5%
Edema face
5%
Encephalopathy
5%
Endocrine disorders
5%
Atelectasis
5%
Atrial fibrillation
5%
Bladder infection
5%
Epistaxis
5%
Flatulence
5%
Gastrointestinal pain
5%
Hematuria
5%
Hemorrhoidal hemorrhage
5%
Hypercalcemia
5%
Neck pain
5%
Nervous system disorders
5%
Pain in extremity
5%
Restlessness
5%
Sinus bradycardia
5%
Sinusitis
5%
Skin and subcutaneous tissue disorder
5%
Skin hyperpigmentation
5%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part B: Dose ExpansionExperimental Treatment2 Interventions
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 will be 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.
Group II: Part A2: Dose EscalationExperimental Treatment2 Interventions
Part A2 will determine the MTD or MAD of SRK-181 in combination with anti-PD-(L)1 antibody therapy and will determine the RP2D of SRK-181 in combination with anti-PD-(L)1 antibody therapy for use in Part B.
Group III: Part A1: Dose EscalationExperimental Treatment1 Intervention
Part A1 will determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of SRK-181 as a single agent and will determine the recommended Phase 2 dose (RP2D) of SRK-181 as a single-agent.
Group IV: Long Term Extension Phase (LTEP)Experimental Treatment2 Interventions
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
Find a Location
Who is running the clinical trial?
Scholar Rock, Inc.Lead Sponsor
3 Previous Clinical Trials
506 Total Patients Enrolled
Lu Gan, MDStudy DirectorScholar Rock, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on cancer treatment but not using anti-PD-(L)1 therapy for Part A2 or B.I agree to use birth control during and for 3 months after the trial.I am a woman who can have children and have a negative pregnancy test.I received anti-PD-(L)1 therapy less than 28 days before starting SRK-181.I can carry out all my usual activities without help.I have taken targeted cancer medication recently before starting SRK-181.I have untreated or symptomatic brain metastases or spinal issues.I have a solid tumor other than NSCLC, UC, MEL, or ccRCC and didn't respond to initial PD-(L)1 therapy.I haven't had biologic therapy (except anti-PD-(L)1 for Part A2/B) in the last 28 days.You have had a severe allergic reaction to anti-PD-(L)1 antibody therapy in the past.I have NSCLC, UC, or MEL and didn’t respond well to initial anti-PD-1 therapy.I haven't had any cancer treatment, including anti-PD-(L)1 therapy, in the last 28 days.My cancer did not improve after at least 3 treatments with specific immune therapy.My NSCLC has specific genetic changes and I've either tried and progressed, couldn't tolerate, or wasn't eligible for targeted therapies.I have clear cell renal cell carcinoma, have been treated with anti-PD-1, and my disease has progressed.My cancer is advanced, and standard treatments are not suitable or have failed.I have another type of cancer, but it's either treated, under observation, or not expected to come back.I am not pregnant or breastfeeding.I haven't had chemotherapy (except with anti-PD-(L)1 therapy) in the last 28 days.I have been diagnosed with an immune system disorder.I had a severe reaction to previous immunotherapy.My body has developed resistance to a specific cancer immunotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Long Term Extension Phase (LTEP)
- Group 2: Part A1: Dose Escalation
- Group 3: Part B: Dose Expansion
- Group 4: Part A2: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is the clinical trial accommodating?
"Scholar Rock, Inc., the study's sponsor, requires 200 eligible participants to conduct their trial. These enrollees may be recruited from Medical College of Wisconsin in Milwaukee and St. Jude Crosson Cancer Institute in Fullerton."
Answered by AI
Has SRK-181 obtained governmental sanction from the FDA?
"Since this is a Phase 1 trial, there exists limited evidence regarding the safety and efficacy of SRK-181. Subsequently, our team at Power has given it an assessment score of 1."
Answered by AI
How many locations are conducting this trial experiment?
"Currently, 12 different medical centres are offering this research trial. These locations include Milwaukee, Fullerton and Tampa along with 9 other sites. Opting to join the closest location can help reduce travel demands associated with participation in this study."
Answered by AI
Are there any available slots for participant enrolment in this research?
"According to clinicaltrials.gov, this study is currently actively enrolling patients. Initially posted on April 23rd 2020 and most recently revised on November 17th 2022, the trial requires more participants."
Answered by AI
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