NSCLCPhase 1/2NCT07902921
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
A Phase 1/2 study testing STAR0602 and Nivolumab in people with NSCLC and Non-Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Immunotherapy is a type of treatment that works by making the body s own immune system stronger. These treatments are used for cancers such as non small cell lung cancer (NSCLC); thymic carcinoma (TC); or metastatic castrate-resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- NSCLC, Non-Small Cell Lung Cancer, Lung Cancer
- What is being tested?
- STAR0602 and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2026to 30 Jun 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- The following tumor types and prior treatments will be included:
- NSCLC: Participants must have received at least one prior approved line of standard therapy. Receipt of prior immune checkpoint inhibitors (ICI) is required unless the participant has a known targetable oncogenic abnormality (e.g., targetable EGFR mutations, KRAS G12C, ALK rearrangement, ROS1 rearrangement, BRAF V600E mutation, NTRK 1/2/3 gene fusion, METex14 skipping mutation, RET rearrangement, ERBB2 [HER2], NRG1 gene fusion) that has been treated with appropriate targeted therapy. Prior ICI therapy is not required for participants with NSCLC harboring a targetable oncogenic abnormality.
- mCRPC: Participants must have received at least one prior line of treatment with enzalutamide and/or abiraterone with the exception of participants who were treated with docetaxel and androgen deprivation therapy (ADT) for mCRPC and progressed on docetaxel treatment or who progressed within one month of the last docetaxel dose. Participants must agree to continue ADT with a gonadotropin-releasing hormone analogue/antagonist or bilateral orchiectomy.
- TC: Participants should have received at least one prior line of standard therapy such as platinum-based chemotherapy. For participants who refuse cytotoxic chemotherapy, a rationale for refusal to receive standard first-line therapy will be captured in the case report form and the medical record. Receipt of prior ICI is permitted.
- Presence of >= 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST)
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- Age >=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- Adequate organ and marrow function as defined below:
- Absolute Neutrophil Count (ANC) >= 1500/mcL
- Platelets >= 75,000/mcL
- Hemoglobin (Hgb) >= 8.5 g/dL
- Total bilirubin <= 1.5 X institutional upper limit of normal (iULN), except participants with Gilbert s syndrome, who may be enrolled if the conjugated bilirubin is within normal limits.
- Aspartate aminotransferase (AST) <= 3 X iULN -OR- <= 5 X ULN for participants with documented metastatic liver disease
- Alanine aminotransferase (ALT) <= 3 X iULN -OR- <= 5 X ULN for participants with documented metastatic liver disease
- Creatinine clearance >= 50 mL/min calculated using estimated glomerular filtration rate (eGFR)
- Castrate testosterone level (<50 ng/dl or 1.7 nmol /L) (in participants with mCRPC only)
- Participants with symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for >= 14 days, are not receiving concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids >10 mg prednisone/day or equivalent), and do not have concurrent leptomeningeal disease or cord compression. Participants with incidentally discovered, asymptomatic CNS metastases that do not require CNS-directed therapy in the judgment of the investigator, are eligible for the trial.
- Human immunodeficiency virus (HIV)-infected participants must have CD4+ T cell (CD4+) counts >= 350 cells/mcL and HIV viral load (VL) < 400 copies/mL.
- Women of child-bearing potential (WOCBP) must agree to use an effective form of contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) while taking study drugs and for 90 days after the last dose of STAR0602 or 5 months after the last dose of nivolumab whichever comes later. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.
- Men must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) while taking study drugs and for 90 days after the last dose of STAR0602 or 5 months after the last dose of nivolumab whichever comes later. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men should refrain from fathering a child or donating sperm during the same period.
- Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 90 days after the last dose of STAR0602 or 5 months after the last dose of nivolumab whichever comes later.
- Participants must be able to understand and willing to sign a written informed consent document.
Who cannot join
- 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.
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- 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
- Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs
- TC-associated paraneoplastic syndromes that do not require systemic immunosuppressive therapy
- Active second malignancy within the past 12 months, except for basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary or follicular thyroid carcinoma, non-muscle invasive bladder cancer and any malignancy that has been definitively/curatively treated without evidence of relapse.
- Participants must not have received major surgeries within 4 weeks prior to the first study drug administration.
- Active infection requiring systemic therapy or significant acute or chronic infections including, among others, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (positive HBV surface antigen [HBsAg] or HCV RNA if anti-HCV antibody test is positive)
- Vaccination with any live virus vaccine within 4 weeks before the initiation of study drug administration.
- Positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test at screening (WOCBP only)
- Severe uncontrolled intercurrent illness as evaluated by history, physical exam, electrocardiogram (EKG) and labs that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937, ncimo_referrals@mail.nih.gov
About this study
Official title: A Phase Ib/II Study of STAR0602 With Nivolumab in Non-Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
Background:
Immunotherapy is a type of treatment that works by making the body s own immune system stronger. These treatments are used for cancers such as non small cell lung cancer (NSCLC); thymic carcinoma (TC); or metastatic castrate-resistant prostate cancer (mCRPC). But these cancers may still come back after treatment.
Read more
Objective:
To test a new immunotherapy drug (STAR0602), alone or combined with an approved drug (nivolumab), in people with NSCLC, mCRPC, or TC.
Eligibility:
People aged 18 years or older with NSCLC, mCRPC, or TC that did not respond to treatment or returned after treatment.
Design: Participants will be screened. They will have blood and urine tests. They will have imaging scans and a test of their heart function.
STAR0602 and nivolumab are given through a needle inserted into a vein (infusion). Participants will be treated in 28-day cycles. They will receive infusions of 1 or both drugs on the first and 15th day of each cycle. They will remain in the hospital for up to 5 days after their first 2 infusions of STAR0602.
Imaging scans, blood tests, and other tests may be repeated during study visits. Participants may opt to have tissue samples (biopsies) taken from their tumors. Some blood and tissue samples may be used for genetic tests.
Participants may continue getting STAR0602 for up to 2 years and nivolumab for up to 6 months.
Participants will have an end-of-study visit within 1 month, and follow-up phone calls 1 month and 3 months, after they stop the study drug. Long-term follow-up calls and visits will continue every 3 to 6 months for up to 5 years.
Read the detailed description
Background:
- Non-small cell lung cancer (NSCLC), which encompasses three main histological subtypes (adenocarcinoma, squamous cell, large cell), accounts for approximately 85% of lung cancers.
- Immunotherapy is utilized in the neoadjuvant and adjuvant settings for resectable NSCLC and is an integral component of frontline therapy for patients with metastatic disease. However, less than 50% of patients with advanced-stage NSCLC respond to immune checkpoint inhibitors (ICIs).
- Among men in the United States, prostate cancer (PC) is the second leading cause of cancer-related mortality. Though androgen deprivation therapy (ADT) is highly effective for advanced-stage PC, most patients will progress to castration resistance.
- Prostate cancer is considered an immunologically "cold" tumor, limiting the effectiveness of immunotherapy alone. However, combining immune checkpoint inhibitors with other systemic treatments - such as androgen receptor-targeting agents, additional ICIs, or targeted therapies like olaparib -may enhance therapeutic efficacy in patients with advanced or aggressive disease.
- Thymic epithelial tumors (TETs) are rare cancers with an annual incidence of 0.48 (for thymic carcinomas [TC]) to 2.2 (for thymomas) per million individuals in the United States. These tumors are characterized by a low tumor mutation burden, a lack of actionable genomic changes, and defects in immune tolerance.
- A subset of patients with TETs treated with ICIs derive durable clinical benefit, and longer survival is observed in patients achieving an objective response as compared to those with stable disease (SD).
- STAR0602 is a fully human, bifunctional antibody that binds to Vbeta6/Vbeta10 T-cell receptors (TCRs) promoting the activation and expansion of predominantly CD8+ Vbeta6/Vbeta10 T cells with augmented cytotoxic function and a central memory-like T cell (TCM) phenotype and upregulation of IL-2 receptor (IL-2R) alpha chain.
- Nivolumab is a monoclonal antibody against PD-1 which has shown an acceptable tolerability profile and antitumor activity in multiple solid tumors.
- STAR0602 may offer a safe and effective therapeutic option for patients who progress after treatment with checkpoint inhibitors (CPIs). Further, preclinical data suggest that objective response and possibly overall survival may be enhanced through use of combination therapy whereby STAR0602 is administered before an anti- programmed cell death protein 1 (PD-1) therapy, such as nivolumab.
Objectives:
- Phase Ib: To determine the safety of STAR0602 monotherapy in participants with thymic carcinoma (TC), and safety of STAR0602 in combination with nivolumab in participants with non-small cell lung cancer (NSCLC) with or without targetable genomic alterations or metastatic castrate-resistant prostate cancer (mCRPC)
- Phase II: To determine the clinical efficacy of STAR0602 alone in participants with TC measured by progression-free survival (PFS)
Eligibility:
- Age >=18 years
- Histologically or cytologically confirmed diagnosis of NSCLC, mCRPC, or TC
- Participants should have at least one measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status <=2
Design:
- This is an open label, nonrandomized Phase Ib/II study assessing the safety and clinical activity of STAR0602 monotherapy in participants with TC, and STAR0602 with nivolumab in participants with NSCLC or mCRPC.
- Participants with TC will receive STAR0602 by intravenous (IV) infusion on Day 1 and 15 of every 28-day cycle.
- Participants with NSCLC or mCRPC will receive STAR0602 and nivolumab by intravenous (IV) infusion on Day 1 and 15 of every 28-day cycle with the exception of Cycle 1 where nivolumab will be only administered on Day 15.
- Participants will receive STAR0602 for up to 24 months (24 cycles) and nivolumab for up to 6 months (6 cycles), or until disease progression or development of intolerable adverse events, whichever occurs first.
- Up to 52 evaluable participants will be enrolled.
- Conditions
- NSCLC, Non-Small Cell Lung Cancer, Lung Cancer, Prostate Cancer, Thymic Epithelial Tumors, TETs
- Being tested
- STAR0602, Nivolumab
- Keywords
- Antibody, T-cell receptors, programmed cell death protein 1 (PD-1)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Prostatic Neoplasms, Thymoma, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR0602Drug
STAR0602 is given intravenously (IV) on day 1 and 15 of every 28-day cycle for up to 24 months (24 cycles)
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | De-escalation doses of STAR0602 + nivolumab Receives: Drug: STAR0602; Drug: Nivolumab |
| Arm 2 | Experimental | Optimal biological dose of STAR0602 + nivolumab Receives: Drug: STAR0602; Drug: Nivolumab |
| Arm 3 | Experimental | De-escalation doses of STAR0602 monotherapy Receives: Drug: STAR0602 |
| Arm 4 | Experimental | Optimal biological dose of STAR0602 monotherapy Receives: Drug: STAR0602 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Secondary outcomes (4)
To evaluate safety of STAR0602 alone during Phase II
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.
Measured: Start of therapy through 90 day post last dose safety visit.
To evaluate the efficacy of STAR0602 + nivolumab as defined by progression free survival (PFS) in participants with NSCLC or mCRPC
Proportion of participants attaining progression free survival (PFS) will be evaluated and reported along with a 95% confidence interval.
Measured: 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.
Determine the overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS) of STAR0602 + nivolumab in participants with NSCLC or mCRPC
Overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS) will be calculated as simple proportions from the on-study date and reported along with a 95% confidence interval for the median time if appropriate, or for selected time points such as at 1 or 2 years.
Measured: For ORR, DCR, DOR: C3D1, C4D1, then every 8 weeks for 1 year and every 12 weeks thereafter for up to 5 years after end of treatment. For OS: Start of therapy through 5 years after completion of treatment.
Determine the overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS) of STAR0602 in participants with TC
Overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS) will be calculated as simple proportions from the on-study date and reported along with a 95% confidence interval for the median time if appropriate, or for selected time points such as at 1 or 2 years.
Measured: For ORR, DCR, DOR: C3D1, C4D1, then every 8 weeks for 1 year and every 12 weeks thereafter for up to 5 years after end of treatment. For OS: Start of therapy through 5 years after completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start11 Nov 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Arun Rajan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902921
- Sponsor's protocol ID
- 10002527
- Other IDs
- 002527-C
- Status last verified
- 26 Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of STAR0602 With Nivolumab in Non-Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
- ClinicalTrials.gov ID
- NCT07902921
- Acronym / sponsor ID
- 10002527
- Conditions
- NSCLC, Non-Small Cell Lung Cancer, Lung Cancer, Prostate Cancer, Thymic Epithelial Tumors, TETs
- Keywords
- Antibody, T-cell receptors, programmed cell death protein 1 (PD-1)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Immunotherapy is a type of treatment that works by making the body s own immune system stronger. These treatments are used for cancers such as non small cell lung cancer (NSCLC); thymic carcinoma (TC); or metastatic castrate-resistant prostate cancer (mCRPC). But these cancers may still come back after treatment.
Objective:
To test a new immunotherapy drug (STAR0602), alone or combined with an approved drug (nivolumab), in people with NSCLC, mCRPC, or TC.
Eligibility:
People aged 18 years or older with NSCLC, mCRPC, or TC that did not respond to treatment or returned after treatment.
Design: Participants will be screened. They will have blood and urine tests. They will have imaging scans and a test of their heart function.
STAR0602 and nivolumab are given through a needle inserted into a vein (infusion). Participants will be treated in 28-day cycles. They will receive infusions of 1 or both drugs on the first and 15th day of each cycle. They will remain in the hospital for up to 5 days after their first 2 infusions of STAR0602.
Imaging scans, blood tests, and other tests may be repeated during study visits. Participants may opt to have tissue samples (biopsies) taken from their tumors. Some blood and tissue samples may be used for genetic tests.
Participants may continue getting STAR0602 for up to 2 years and nivolumab for up to 6 months.
Participants will have an end-of-study visit within 1 month, and follow-up phone calls 1 month and 3 months, after they stop the study drug. Long-term follow-up calls and visits will continue every 3 to 6 months for up to 5 years.
Detailed description
Background:
- Non-small cell lung cancer (NSCLC), which encompasses three main histological subtypes (adenocarcinoma, squamous cell, large cell), accounts for approximately 85% of lung cancers.
- Immunotherapy is utilized in the neoadjuvant and adjuvant settings for resectable NSCLC and is an integral component of frontline therapy for patients with metastatic disease. However, less than 50% of patients with advanced-stage NSCLC respond to immune checkpoint inhibitors (ICIs).
- Among men in the United States, prostate cancer (PC) is the second leading cause of cancer-related mortality. Though androgen deprivation therapy (ADT) is highly effective for advanced-stage PC, most patients will progress to castration resistance.
- Prostate cancer is considered an immunologically "cold" tumor, limiting the effectiveness of immunotherapy alone. However, combining immune checkpoint inhibitors with other systemic treatments - such as androgen receptor-targeting agents, additional ICIs, or targeted therapies like olaparib -may enhance therapeutic efficacy in patients with advanced or aggressive disease.
- Thymic epithelial tumors (TETs) are rare cancers with an annual incidence of 0.48 (for thymic carcinomas [TC]) to 2.2 (for thymomas) per million individuals in the United States. These tumors are characterized by a low tumor mutation burden, a lack of actionable genomic changes, and defects in immune tolerance.
- A subset of patients with TETs treated with ICIs derive durable clinical benefit, and longer survival is observed in patients achieving an objective response as compared to those with stable disease (SD).
- STAR0602 is a fully human, bifunctional antibody that binds to Vbeta6/Vbeta10 T-cell receptors (TCRs) promoting the activation and expansion of predominantly CD8+ Vbeta6/Vbeta10 T cells with augmented cytotoxic function and a central memory-like T cell (TCM) phenotype and upregulation of IL-2 receptor (IL-2R) alpha chain.
- Nivolumab is a monoclonal antibody against PD-1 which has shown an acceptable tolerability profile and antitumor activity in multiple solid tumors.
- STAR0602 may offer a safe and effective therapeutic option for patients who progress after treatment with checkpoint inhibitors (CPIs). Further, preclinical data suggest that objective response and possibly overall survival may be enhanced through use of combination therapy whereby STAR0602 is administered before an anti- programmed cell death protein 1 (PD-1) therapy, such as nivolumab.
Objectives:
- Phase Ib: To determine the safety of STAR0602 monotherapy in participants with thymic carcinoma (TC), and safety of STAR0602 in combination with nivolumab in participants with non-small cell lung cancer (NSCLC) with or without targetable genomic alterations or metastatic castrate-resistant prostate cancer (mCRPC)
- Phase II: To determine the clinical efficacy of STAR0602 alone in participants with TC measured by progression-free survival (PFS)
Eligibility:
- Age >=18 years
- Histologically or cytologically confirmed diagnosis of NSCLC, mCRPC, or TC
- Participants should have at least one measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status <=2
Design:
- This is an open label, nonrandomized Phase Ib/II study assessing the safety and clinical activity of STAR0602 monotherapy in participants with TC, and STAR0602 with nivolumab in participants with NSCLC or mCRPC.
- Participants with TC will receive STAR0602 by intravenous (IV) infusion on Day 1 and 15 of every 28-day cycle.
- Participants with NSCLC or mCRPC will receive STAR0602 and nivolumab by intravenous (IV) infusion on Day 1 and 15 of every 28-day cycle with the exception of Cycle 1 where nivolumab will be only administered on Day 15.
- Participants will receive STAR0602 for up to 24 months (24 cycles) and nivolumab for up to 6 months (6 cycles), or until disease progression or development of intolerable adverse events, whichever occurs first.
- Up to 52 evaluable participants will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: STAR0602, Drug: NivolumabDe-escalation doses of STAR0602 + nivolumab |
| Arm 2 | Experimental | Drug: STAR0602, Drug: NivolumabOptimal biological dose of STAR0602 + nivolumab |
| Arm 3 | Experimental | Drug: STAR0602De-escalation doses of STAR0602 monotherapy |
| Arm 4 | Experimental | Drug: STAR0602Optimal biological dose of STAR0602 monotherapy |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
- The following tumor types and prior treatments will be included:
- Presence of >= 1 measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST)
- Age >=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status <= 2
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR0602STAR0602 is given intravenously (IV) on day 1 and 15 of every 28-day cycle for up to 24 months (24 cycles) | Drug | Arm 1, Arm 2, Arm 3, Arm 4 |
| NivolumabNivolumab 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) | Drug | Arm 1, Arm 2 |
Primary outcome
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
Time frame: Start of therapy through 90 day post last dose safety visit.
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.
Phase II: Determine the clinical efficacy of STAR0602 alone in participants with TC measured by progression free survival (PFS)
Time frame: 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.
Proportion of participants attaining progression free survival (PFS) will be evaluated and reported along with a 95% confidence interval.
4 secondary outcomes
To evaluate safety of STAR0602 alone during Phase II
Time frame: Start of therapy through 90 day post last dose safety visit.
To evaluate the efficacy of STAR0602 + nivolumab as defined by progression free survival (PFS) in participants with NSCLC or mCRPC
Time frame: 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.
Determine the overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS) of STAR0602 + nivolumab in participants with NSCLC or mCRPC
Time frame: For ORR, DCR, DOR: C3D1, C4D1, then every 8 weeks for 1 year and every 12 weeks thereafter for up to 5 years after end of treatment. For OS: Start of therapy through 5 years after completion of treatment.
Determine the overall response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS) of STAR0602 in participants with TC
Time frame: For ORR, DCR, DOR: C3D1, C4D1, then every 8 weeks for 1 year and every 12 weeks thereafter for up to 5 years after end of treatment. For OS: Start of therapy through 5 years after completion of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arun Rajan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STAR0602 and Nivolumab in people with NSCLC and Non-Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine A Feierabend ((240) 858-7397, chris.feierabend@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Start of therapy through 90 day post last dose safety visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.