Trials Sponsors Conditions Drugs Pricing

Conditions

NSCLC Non-Small Cell Lung Cancer Lung Cancer Prostate Cancer Thymic Epithelial Tumors TETs Thymic Carcinomas Thymomas Metastatic Castrate-resistant Prostate Cancer mCRPC

Keywords

AntibodyT-cell receptorsprogrammed cell death protein 1 (PD-1)

Outcome Measures

Primary Outcomes (2)

Phase Ib: Determine the safety of STAR0602 monotherapy in participants with TC, and safety of STAR0602 in combination with nivolumab in participants with NSCLC with or without targetable genomic alterations or mCRPC
The number of adverse events by grade and type will be reported in each cohort along with a 95% confidence interval. Dose-limiting toxicities (DLTs) will also be collected and reported by type, grade, and frequency.
Start of therapy through 90 day post last dose safety visit.
Phase II: Determine the clinical efficacy of STAR0602 alone in participants with TC measured by progression free survival (PFS)
Proportion of participants attaining progression free survival (PFS) will be evaluated and reported along with a 95% confidence interval.
Cycle 3 Day 1, Cycle 4 Day 1, then every 8 weeks for the first year and every 12 weeks thereafter until disease progression, start of another systemic therapy, or 5 years after completion of study treatment.

Study Arms (4)

Arm 1

EXPERIMENTAL

De-escalation doses of STAR0602 + nivolumab

Drug: STAR0602Drug: Nivolumab

Arm 2

EXPERIMENTAL

Optimal biological dose of STAR0602 + nivolumab

Drug: STAR0602Drug: Nivolumab

Arm 3

EXPERIMENTAL

De-escalation doses of STAR0602 monotherapy

Interventions

STAR0602Drug

STAR0602 is given intravenously (IV) on day 1 and 15 of every 28-day cycle for up to 24 months (24 cycles)

Arm 1Arm 2Arm 3Arm 4

NivolumabDrug

Nivolumab is given intravenously (IV) on day 1 and 15 of every 28-day cycle (with the exception of cycle 1 where nivolumab will only be administered on day 15) for up to 6 months (6 cycles)

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants must have histologically or cytologically confirmed NSCLC, mCRPC, or TC (by outside pathology report or via the NCI Laboratory of Pathology \[LP\]) that is unresectable, locally-advanced, or metastatic, and for which standard curative therapies do not exist or are no longer effective. Progressive disease must be documented prior to study entry.

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHlead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

National Cancer Institute Referral OfficeCONTACT888-624-1937 ncimo_referrals@mail.nih.gov

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsProstatic NeoplasmsThymomaParkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

Arun Rajan, M.D.
National Cancer Institute (NCI)
PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine A Feierabend

CONTACT

(240) 858-7397 chris.feierabend@nih.gov

Arun Rajan, M.D.

CONTACT

(240) 760-6236

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 28, 2026

First Posted

October 29, 2026

Study Start

November 3, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 31, 2029

Estimated

You may not qualify if:

History of allergic reactions attributed to compounds of similar chemical or biologic composition to STAR0602, or other agents used in study.
Detectable acetylcholine receptor autoantibodies or anti-striational antibodies due to the risk of immune myositis (for participants with TC only).
Persisting toxicity related to prior therapy (NCI CTCAE Grade \> 1 or baseline) with the exception of, alopecia, sensory neuropathy Grade \<= 2 and hearing loss Grade \<= 2. Note: Prior ICI-related endocrine abnormalities are permitted regardless of grade if receiving replacement therapy.
Participants with history of prior ICI-related Grade \> 3 pneumonitis, pericarditis, myocarditis, colitis or any neurological or neuromuscular toxicities.
Treatment with \>10 mg per day of prednisone (or equivalent) or other immunesuppressive drugs within 7 days prior to the initiation of study drug (or 5 half-lives of the drug, whichever is shorter). Exceptions will be made for participants who have had an allergic reaction to iodinated contrast media or those receiving hormonal replacement therapy for previously diagnosed endocrinopathies. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.
Participants receiving any other investigational agents.
Prior therapy within the following timeframe with:
Cytotoxic chemotherapy, ICI, small molecule inhibitors, radiation, interventional radiology procedure, or similar investigational therapies within 2 weeks prior to the initiation of study drug(s);
Monoclonal antibodies (except ICIs), antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies within 6 weeks prior to the initiation of study drug.
Note: Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes, hormone replacement therapy) or use of gonadotropin-releasing hormone analogue/antagonist for androgen deprivation in mCRPC is acceptable. Bisphosphonates or denosumab are permitted for supportive care of bone metastases. Palliative radiotherapy is permitted to non-target lesions.
Known autoimmune disease except for:
Vitiligo
Psoriasis, atopic dermatitis, or other autoimmune skin condition not requiring systemic treatment
Endocrinopathies managed by endocrine replacement therapy
Alopecia
+8 more criteria

STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (4)

Arm 1

Arm 2

Arm 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (4)

Arm 4

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (4)

Arm 1

Arm 2

Arm 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (4)

Arm 4

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations