A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Subjects with Unresectable, Locally Advanced, or Metastatic Solid Tumors that are Antigen-rich (START-001)

Cancer Categories

Gastrointestinal (GI),Genitourinary (GU),Gynecologic

Karmanos Trial ID

2024-091

NCT ID

NCT05592626

Age Group

Adult

Scope

National

Phase

Phase I/II

Principal Investigator

Wasif
Saif, M.D., MBBS
Oncology - Medical View Profile

Objective:

Primary Objectives:

Phase 1: Dose Escalation

To characterize the safety, tolerability, and dose-limiting toxicities (DLTs), and determine the recommended Phase 2 dose (RP2D) of STAR0602

Phase 2: Dose Expansion

To further explore anti-tumor activity of STAR0602 in unresectable, locally advanced, or metastatic solid tumors

Secondary Objectives:

Phase 1: Dose Escalation

To evaluate preliminary antitumor activity of STAR0602 in unresectable, locally advanced, or metastatic solid tumors
To evaluate the PK profile of STAR0602 in serum after single and repeated IV infusions

Phase 2: Dose Expansion

To further evaluate the antitumor activity of STAR0602
To evaluate the PK profile of STAR0602 in serum after single and repeated IV infusions
To further characterize the safety and tolerability of STAR0602

Phase 1 and Phase 2: Dose Escalation and Dose Expansion

To assess antidrug antibody (ADA) formation after IV single and repeat dose administration of STAR0602

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Eligibility

Inclusion Criteria:

Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Subjects should not have received more than three lines of prior therapies for their advanced or metastatic diseases.
For Phase 1, participants must have one of the following solid tumors:

High mutational burden (TMB-H)
Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)
Virally associated tumors

For Phase 2, participants must have one of the following solid tumors:

TMB-H
MSI-H/dMMR
CRC (both Ras wild type and mutant)
Virally associated tumors
Metastatic triple negative breast cancer
Platinum-resistant epithelial ovarian cancer
Metastatic castration-resistance prostate cancer
Primary stage IV or recurrent non-small cell lung cancer
Immunogenic solid tumors

(Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)

Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:

No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids > 10 mg prednisone/day or equivalent);
No concurrent leptomeningeal disease or cord compression.

Exclusion Criteria:

Participants with a history of known autoimmune disease with exceptions of:

Vitiligo;
Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;
History of Graves' disease, now euthyroid for > 4 weeks;
Hypothyroidism managed by thyroid replacement;
Alopecia;
Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.
Adrenal insufficiency well controlled on replacement therapy.

Major surgery or traumatic injury within 8 weeks before first dose of study drug.
Unhealed wounds from surgery or injury.
Treatment with >10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.
Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.
Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.
Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices