Breast Cancer Clinical Trial

Phase 1a and Phase 2 Study for PK, PD, Safety and Preliminary Efficacy of ST-067

Summary

This is a multicenter Phase 1a open-label, dose escalation study, and a Phase 2 study of ST-067. Phase 1a is a first-in-human (FIH) dose escalation study in patients aged 18 years or older diagnosed with solid tumors who have exhausted available standard. Phase 2 will enroll patients aged 18 years or older diagnosed with the following solid tumors: melanoma, renal cell carcinoma, triple negative breast cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and microsatellite instability-high tumors.

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Full Description

Phase 1a is designed to determine the recommended Phase 2 dose of ST-067 monotherapy using a modified toxicity probability interval (mTPI) design. ST-067 is administered as subcutaneous injection once weekly. Pre and on treatment biopsies will be mandated for all patients. There will be evaluation of PK and PD effects.

Phase 2 will evaluate the preliminary efficacy of ST-067 administered at the RP2D to patients with the following tumor types. A Simon 2 stage design is used to calculate the sample size and early stopping rules will be employed in the event of lack of efficacy in any of the cohorts. RECIST 1.1 will be used to assess tumor response every 8-12 weeks.

Melanoma (n=28)
Renal cell carcinoma (n=25)
Triple-negative best cancer (n=25)
Non-small cell lung cancer (n=25)
squamous cell carcinoma of the head and neck (n=28)
MSI-Hi tumors (n=25)

Safety will be assessed for each patient throughout the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male and female patients aged ≥18 years
Must provide written informed consent and any authorizations required by local law
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor

For Phase 1a, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC,TNBC, SCCHN, microsatellite instability high, high tumor mutation burden (Hi TMB) or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, hepatocellular carcinoma and platinum resistant ovarian cancer.

For patients who have developed disease progression through standard therapy, or
For patients whom standard of care therapy that prolongs survival is not available or suitable (according to the investigator and after consultation with the Medical Monitor)

For Phase 2, the following solid tumors are allowed:

Melanoma, RCC, TNBC, NSCLC, SCCHN, and MSI-Hi tumors

Has at least 1 measurable lesion per RECIST 1.1 criteria which has not been biopsied or received prior irradiation
Has an accessible tumor for biopsy pre- and on-treatment (mandatory).

Exclusion Criteria:

History of another malignancy
Known symptomatic brain metastases requiring >10 mg/day of prednisolone
Significant cardiovascular disease
Significant ECG abnormalities i
Evidence of an ongoing systemic bacterial, fungal, or viral infection
Has received a live vaccine within 30 days
Major surgery within 4 weeks
Prior solid organ or bone marrow progenitor cell transplantation
Prior high dose chemotherapy requiring stem cell rescue
History of active autoimmune disorders
Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

198

Study ID:

NCT04787042

Recruitment Status:

Recruiting

Sponsor:

Simcha IL-18, Inc.

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There are 6 Locations for this study

See Locations Near You

HonorHealth Research Institute
Scottsdale Arizona, 85258, United States More Info
Justin Moser, MD
Contact
833-354-6667
Justin Moser, MD
Principal Investigator
Sarah Cannon Research Institute at HealthONE
Denver Colorado, 80218, United States More Info
Gerald Falchook, MD, MS
Contact
720-754-2610
Gerald Falchook, MD
Principal Investigator
Yale Cancer Center
New Haven Connecticut, 06519, United States More Info
Harriet Kluger, MD
Contact
203-785-4095
Harriet Kluger, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Ryan Sullivan, MD
Contact
617-724-4000
Ryan Sullivan, MD
Principal Investigator
Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Igor Puzanov, MD
Contact
716-845-1300
Igor Puzanov, MD
Principal Investigator
Providence Cancer Institute Franz Clinic
Portland Oregon, 97213, United States More Info
Matthew Taylor, MD
Contact
503-215-5696
Matthew Taylor, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

198

Study ID:

NCT04787042

Recruitment Status:

Recruiting

Sponsor:


Simcha IL-18, Inc.

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