Study of STK-012 Alone and with Other Treatments in Patients with Advanced Lung Cancer and Other Cancers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Synthekine Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

11 May 2026 → ongoing

Decision date (initial)

2026-01-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Synthekine, Inc.

External identifiers

EU CT number

2025-522632-14-00

ClinicalTrials.gov

NCT05098132

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Others, Efficacy

To compare the ORR in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 2.25mg + PCT vs. PCT (Arms A vs. C)

Secondary objectives 8

1. To compare the PFS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 2.25 mg + PCT vs. PCT (Arms A vs. C)
2. To compare the ORR in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 1.5 mg + PCT vs. PCT (Arms B vs. C)
3. To compare the PFS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 1.5 mg + PCT vs. PCT (Arms B vs. C)
4. To compare the OS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 2.25 mg + PCT vs. PCT (Arms A vs. C)
5. To compare the OS in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 1.5 mg + PCT vs. PCT (Arms B vs. C)
6. To assess the safety of STK-012 therapy in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 + PCT vs. PCT
7. To assess the immunogenicity of STK-012 in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 + PCT
8. To assess the PK of STK-012 in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 + PCT

Conditions and MedDRA coding

Non-small cell lung cancer (NSCLC)

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 17

1. 01. Provide written informed consent to participate in the study and follow the study procedures.
2. 11. Subjects are able and willing to complete the entire study according to the applicable study schedule of assessments.
3. 12. Subjects must have histologically or cytologically confirmed diagnosis of stage IV (M1a, M1b or M1c per AJCC 8th edition) or stage IIIB/IIIC (N2 or N3 per AJCC 8th edition) NSQ NSCLC if they are not candidates for definitive treatment.
4. 13. Subject’s tumor must have predominantly non-squamous cell histology NSCLC. Subject’s tumor must not have small cell, neuroendocrine or sarcomatoid components.
5. 14. No known AGAs by tumor or ctDNA testing in EGFR, ALK, or ROS1 or other AGAs for which there is a local SoC available as 1L therapy.
6. 15. Subjects must have a tumor that is negative for PD-L1 (TPS <1%) per local assessment
7. 16. Subjects must not have received prior systemic treatment for their advanced NSQ NSCLC.
8. 02. Male and female subjects age ≥18 years on day of signing ICF.
9. 03. Life expectancy >3 months as determined by the investigator.
10. 04. Subjects must have measurable disease by RECIST 1.1 as assessed by the local site investigator or radiology department. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
11. 05. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
12. 06. Adequate organ function within 28 days of treatment initiation, as defined by the protocol.
13. 07. Female subjects of childbearing potential must agree to use a highly effective method of birth control, as defined by the protocol.
14. 08. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours of the first dose of study treatment.
15. 09. Male subjects with female partners of childbearing potential must agree to use highly effective methods of birth control, as defined by the protocol, or a male condom plus spermicide and must refrain from donating sperm during the treatment period and for 180 days after the last dose of study treatment.
16. 10. Female partners (of childbearing potential) of male subjects must also use a highly effective method of birth control, as defined by protocol, during the treatment period and for 180 days after the last dose of study treatment, if the male subject’s only birth control method is male condom plus spermicide.
17. 17. Subjects who received adjuvant, neoadjuvant or consolidation chemotherapy are eligible if the therapy was completed >6 months prior to initiation of study treatment. Subjects must not have received any prior adjuvant, neoadjuvant or consolidation ICI therapy.

Exclusion criteria 22

1. 01. Received systemic anti-cancer therapy within 3 weeks of the first dose of study treatment or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
2. 02. Received radiotherapy ≤ 7 days prior to the 1st dose of study treatment.
3. 03. Received prior IL-2-based or IL-15-based cytokine therapy.
4. 04. History of idiopathic pulmonary fibrosis (including pneumonitis), drug or radiation induced pneumonitis, organizing pneumonia (ie, bronchiolitis obliterans and cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan.
5. 05.Currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment. Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
6. 06. Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anti-cancer treatment to Grade ≤2.
7. 07. Any history of carcinomatous meningitis.
8. 08. Known untreated central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 7 days prior to first dose of study treatment.
9. 09. Severe hypersensitivity (NCI CTCAE Grade ≥3) to monoclonal antibodies, including pembrolizumab and/or any of its excipients.
10. 10. Known active or history of autoimmune disease or a syndrome that requires steroids or immunosuppressive agents. Subjects are permitted to enroll if they have vitiligo, type 1 diabetes mellitus, resolved childhood asthma; residual hypo- or hyperthyroidism due to an autoimmune condition not requiring immunosuppressive treatment; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs).
11. 11. Diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Exceptions include inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted.
12. 12. History of allogenic tissue/solid organ transplant.
13. 13. Clinically significant (ie. active) cardiovascular disease or risk factors at screening, as defined by the protocol.
14. 14. History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than their primary malignancy, that in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.
15. 15. Subjects with uncontrolled intercurrent illnesses, including immune colitis, interstitial lung disease, or a history of immune pneumonitis or pulmonary fibrosis that required oral or intravenous glucocorticoids.
16. 16. Evidence of any serious active bacterial, viral, parasitic, or systemic fungal infections requiring systemic therapy within the 30 days prior to the first dose of study drug.
17. 17. Known additional malignancy that is progressing or has required active treatment within the past 2 years. Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma and CC in situ) that have undergone potentially curative therapy are not excluded.
18. 18. Receipt of a live-virus vaccine within 30 days prior to first dose of study drug and while on study (seasonal flu vaccines and coronavirus disease 2019 [COVID-19] vaccines that do not contain live-virus are permitted).
19. 19. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
20. 20. HIV infection confirmed during the Screening Period by a positive serum HIV test.
21. 21. Active hepatitis B virus infection or hepatitis C virus (HCV) infection confirmed during the Screening Period by a positive hepatitis B surface antigen or positive anti-hepatitis C virus antibody (anti-HCV) test. Exceptions include subjects with a reactive or indeterminate/equivocal anti-HCV test with a negative HCV RNA test.
22. 22. Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, defined as starting with the screening visit through 180 days after the last dose of study treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per blinded independent central review (BICR).

Secondary endpoints 6

1. PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.
2. ORR is the proportion of subjects with confirmed CR or confirmed PR per BICR.
3. OS is the time from randomization until death due to any cause.
4. Safety including but not limited to: TEAEs, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE v5.0 except for CRS, which will be graded according to the ASTCT guidelines.
5. Incidence of STK-012 antibodies and qualitative assessment of safety outcomes.
6. PK characterization of STK-012 (eg, AUC, Cmax, Tmax, t1/2).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Synthekine Inc.

Sponsor organisation

Synthekine Inc.

Address

1505 Obrien Drive

City

Menlo Park

Postcode

94025-1435

Country

United States

Scientific contact point

Organisation

Synthekine Inc.

Contact name

STK Contact

Public contact point

Organisation

Synthekine Inc.

Contact name

STK Contact

Third parties 1

Locations

4 EU/EEA countries · 29 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 37 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications