SRK-181 for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
CancerSRK-181 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 6 months

6 months
Anti-tumor activity of SRK-181, alone or in combination wit anti-PD-(L)1 antibody therapy as potential indicators of clinical response
Day 21
PK of SRK-181 alone and in combination with anti-PD-(L)1 antibody therapy
Day 21
Safety and tolerability of SRK-181 in combination with anti-PD-(L)1 antibody therapy
Safety and tolerability of single agent SRK-181

Trial Safety

Safety Progress

1 of 3

Side Effects for

Arm B (Temsirolimus)
75%Fatigue
65%Anemia
48%Hyperglycemia
43%Lymphocyte count decreased
38%Anorexia
35%Constipation
35%Cough
35%Platelet count decreased
35%Nausea
30%Pain
30%Mucositis oral
28%White blood cell decreased
28%Hypoalbuminemia
28%Dyspnea
25%Hypertriglyceridemia
25%Alanine aminotransferase increased
25%Cholesterol high
23%Dysphagia
20%Depression
20%Fever
20%Weight loss
20%Hypophosphatemia
18%Hyponatremia
18%Insomnia
18%Alkaline phosphatase increased
18%Aspartate aminotransferase increased
18%Hypocalcemia
18%Hypokalemia
18%Headache
18%Non-cardiac chest pain
15%Peripheral sensory neuropathy
15%Creatinine increased
15%Vomiting
15%Edema face
15%Neck pain
13%Rash maculo-papular
13%Diarrhea
13%Dysgeusia
13%Rash acneiform
13%Infections and infestations - Other
10%Dizziness
10%Edema limbs
10%Arthralgia
10%Neutrophil count decreased
8%INR increased
8%Respiratory failure
8%Facial pain
8%Anxiety
8%Back pain
8%Pneumonitis
8%Hypertension
8%Dry mouth
8%Dry skin
8%Pruritus
8%Neck edema
8%Oral dysesthesia
5%Generalized muscle weakness
5%Sore throat
5%Hypomagnesemia
5%Tumor pain
5%General disorders and administration site conditions - Other
5%Urinary frequency
5%Myalgia
5%Hypernatremia
5%Chills
5%Dehydration
5%Ear pain
5%Epistaxis
5%Hypercalcemia
5%Hearing impaired
5%Pleural effusion
5%Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
5%Allergic rhinitis
5%Skin infection
5%Gastroesophageal reflux disease
5%Dyspepsia
5%Leukocytosis
5%Papulopustular rash
5%Hyperkalemia
5%Lung infection
5%Lymphedema
5%Sinusitis
3%Anorectal infection
3%Peripheral motor neuropathy
3%Blurred vision
3%Oral pain
3%Respiratory, thoracic and mediastinal disorders - Other
3%Skin and subcutaneous tissue disorders - Other
3%Laryngeal obstruction
3%Vertigo
3%Pleuritic pain
3%Palmar-plantar erythrodysesthesia syndrome
3%Stridor
3%Tracheostomy site bleeding
3%Alopecia
3%Postnasal drip
3%Eye disorders - Other
3%Hypoxia
3%Heart failure
3%Pharyngeal hemorrhage
3%Tracheal hemorrhage
3%Pleural infection
3%Pneumothorax
3%Skin ulceration
3%Hypotension
This histogram enumerates side effects from a completed 2013 Phase 2 trial (NCT01256385) in the Arm B (Temsirolimus) ARM group. Side effects include: Fatigue with 75%, Anemia with 65%, Hyperglycemia with 48%, Lymphocyte count decreased with 43%, Anorexia with 38%.

Trial Design

4 Treatment Groups

Part A1: Dose Escalation
1 of 4
Long Term Extension Phase (LTEP)
1 of 4
Part B: Dose Expansion
1 of 4
Part A2: Dose Escalation
1 of 4

Experimental Treatment

200 Total Participants · 4 Treatment Groups

Primary Treatment: SRK-181 · No Placebo Group · Phase 1

Part A1: Dose Escalation
Biological
Experimental Group · 1 Intervention: SRK-181 · Intervention Types: Biological
Long Term Extension Phase (LTEP)Experimental Group · 2 Interventions: anti-PD-(L)1 antibody therapy, SRK-181 · Intervention Types: Biological, Biological
Part B: Dose ExpansionExperimental Group · 2 Interventions: anti-PD-(L)1 antibody therapy, SRK-181 · Intervention Types: Biological, Biological
Part A2: Dose EscalationExperimental Group · 2 Interventions: anti-PD-(L)1 antibody therapy, SRK-181 · Intervention Types: Biological, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Scholar Rock, Inc.Lead Sponsor
3 Previous Clinical Trials
522 Total Patients Enrolled
Lu Gan, MDStudy DirectorScholar Rock, Inc.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically documented solid tumor that is metastatic or locally advanced, for which there is no available therapy.
You 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.
You 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.
Up to 3 lines of treatment are allowed between the last dose of anti-PD-1 and enrollment.
You have measurable disease per RECIST v1.1 as assessed at Screening.
Patient must have an Eastern Cooperative Oncology Group performance status (PS) 0-1.
Patients must have a genomic tumor aberrations for which a targeted therapy is available.