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-BG
• Lead Sponsor: MAIA Biotechnology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-29
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 176

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 4 histologically or cytologically confirmed NSCLC which has progressed or relapsed after treatment in the advanced setting
• Stage 4 subjects – must have progressed or relapsed after first line treatment.
• Stage 3 subjects – must have already failed, or be ineligible for, local,
curative-intent therapy including surgery and/or chemoradiation. Stage 3 subjects with documented relapse/progression after consolidation therapy with durvalumab following definitive chemoradiotherapy are eligible.
• 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. Only one prior treatment for NSCLC in the advanced setting, which must have included one anti-PD-1/PD-L1 agent with documented radiographic disease progression on or after treatment.
• Prior treatment may have been with anti-PD-1/PD-L1 agent either alone or in combination with a non-anti-PD-1/PD-L1 treatment (e.g., chemotherapy).
• Prior platinum-based chemotherapy is not required for eligibility.
• Subjects receiving more than one ICI in the advanced setting (e.g., anti-PD-1/PD-L1 and anti-CTLA-4 compounds) will not be eligible.
4. At least one measurable target lesion that meets the definition of
RECIST v1.1.
5. 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
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-
1.
7. 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.
Gender and Reproductive Considerations
8. 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.
9.Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
10. 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.
11. 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 dos

Exclusion Criteria

Medical Conditions
1. Have not recovered from adverse events (must be Grade =1) due to prior anti-cancer
treatment.
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.
Prior Therapy
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. Prior treatment with cemiplimab.
16. Undergone major surgery within 4 weeks prior to Cycle 1, Day 1.
17. Received blood, red blood cell or platelet transfusion within 2 weeks
before the first dose of IP.
18. 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 vacc

Study & Design

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