A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced with Cemiplimab (LIBTAYO®) in Subjects with Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 1

• Conditions: on-Small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-005136-34-PL
• Lead Sponsor: MAIA Biotechnology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-29
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

1. At least 18 years of age at the time of signing the Informed Consent Form (ICF) prior to initiation of any study specific activities/procedures.
2. Stage 3 or Stage 4 NSCLC (histologically or cytologically confirmed) which either hasprogressed or relapsed after first line treatment in the advanced setting (prior treatment with PD-1/PD-L1 checkpoint inhibitor alone and/or in combination with platinum-based chemotherapy is permitted)
• Most recent treatment regimen must have included an ICI with radiographic disease progression on or after treatment.
• Stage 3 subjects must have already failed, or be ineligible for, local, curative-intent therapy including surgery.
• Patients with primary resistance, as defined by the Society for Immunotherapy of Cancer (SITC) immunotherapy resistance task force, are excluded:
• Subjects with drug exposure >6 weeks who achieved a PR or CR, then progressed before 6 months would still be eligible.
3. At least one measurable target lesion that meets the definition of RECIST v1.1.
4. An archival tissue sample (FFPE tissue block or unstained slides) is required if tissue is available at baseline. Sample does not need to be received by central lab prior to C1D1. Subjects without archival tissue available at baseline may be eligible with medical monitor approval.
Diagnostic Assessments
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. Demonstrate adequate organ function as defined below. All screening laboratories should be performed up 14 days before initiating IP:
• Bone marrow function: neutrophil count = 1500/mm3, hemoglobin = 9.0 g/dL, platelet count = 100,000/mm3;
• Liver function:
Total bilirubin = 1.5 x the upper limit of normal (ULN), up to = 3 x ULN due to Gilbert’s syndrome
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 1.5 xULN. For subjects with liver metastases present at baseline, ALT and/or AST= 3xULN iis permitted.
Renal function: Creatinine clearance = 60 mL/min calculated by the Cockcroft-Gault formula using actual body weight or 24-hour urine collection.
7. Women of childbearing potential (WOCBP) must have negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to receiving the first administration of IP.
8. WOCBP must agree to use a highly effective birth control and refrain from oocyte donation during the study (prior to the first dose with THIO, for the duration of the treatment with THIO plus 6 months after last dose of IP), if conception is possible during this interval.
9. Male subjects and WOCBP partners of male subjects should use a combination of the methods specified in Section 10.4 for the women along with a male condom from first dose of THIO (Cycle 1, Day 1), for the duration of the treatment with THIO plus 6 months after last dose of IP, unless permanently sterile by bilateral orchidectomy. Male subjects should also refrain from sperm donation during this time.
10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

1. Have not recovered from adverse events (must be Grade =1) due to agents administered more than 4 weeks earlier.
2. Untreated or symptomatic central nervous system (CNS) metastases. Note: subjects with treated asymptomatic brain metastasis are eligible.
3. Active gastrointestinal bleeding as evidenced by either hematemesis or melena.
4. History of another concurrent malignancy other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.
5. A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, adrenal replacement doses 10 mg daily prednisone equivalents, and systemic corticosteroids to manage adverse events (AEs) are
permitted in the absence of active autoimmune disease.
6. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 2 weeks of screening.
7. Positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active hepatitis B or hepatitis C.
8. Significant cardiovascular impairment (history of New York Heart Association Functional Classification System Class III or IV) or a history of myocardial infarction or unstable angina within the past 6 months prior to IP initiation.
a) QTcF > 480 msec at screening (based on average of triplicate ECGs at baseline).
i. If the QTc is prolonged in a subject with a pacemaker or bundle branch block, the subject may be enrolled in the study if confirmed by the medical monitor.
9. Ongoing immune-related/stimulated adverse events (irAEs) from other agents or required permanent discontinuation of prior ICIs due to irAEs. Subjects with resolved irAE will be allowed to enroll following consultation with Sponsor’s Medical Monitor (or designee).
10. Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions:
Controlled type 1 diabetes;
Hypothyroidism (provided it is managed with hormone-replacement therapy only);
Controlled celiac disease;
Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);
Any other disease that is not expected to recur in the absence of external triggering factors.
11. Pregnancy or lactating.
12. A serious nonmalignant disease (e.g., psychiatric, substance abuse, uncontrolled intercurrent illness, etc.) that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor.
13. Any other condition that, in the opinion of the investigator, would prohibit the subject from participating in the study.
14. Prior chemotherapy and/or non-biologic targeted therapy within 4 weeks, or biologic targeted therapy, immunotherapy and/or radiation therapy within 6 weeks prior to Cycle 1 Day 1. Subjects who receive targeted radiation therapy for localized palliative care may be eligible to start treatment < 6 weeks with medical monitor agreement.
15. Undergone major surgery within 4 weeks prior to Cycle 1, Day 1.
16. Received blood, red blood cell or platelet transfusion within 2 weeks before the first dose of IP.
17. Any live, attenuated, inactivated or research vaccines within 30 days prior to the first dose of IP. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed.
18. Prior allogeneic hematopoietic stem

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified