A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 300

Inclusion Criteria

Parts A and A-2 are not conducted in EU/EEA and, therefore, specific inclusion criteria are not described.

Part B:
• Patients with Non-small Cell Lung Cancer (NSCLC) or other protocol-specified solid tumors with locally advanced or metastatic, non-resectable disease, which has progressed despite treatment with first-line standard-of-care treatment, or first- and second-line treatment, dependent on expansion cohort.
• Prior therapy must have been completed 2-4 weeks prior to the administration of the first dose of study drug as specified per protocol according to type of prior therapy.

Part B: (all cohorts): Patients with locally advanced or metastatic, nonresectable disease per cohort specific criteria listed in the protocol:
• Cohorts B1, B3, and B7
o Patients with NSCLC

•Cohort B2
o Patients with HPV-associated (i.e. HPV+ tumor) SCC of the anus, cervix, vulva, vagina, penis or oropharynx

•Cohort B4
o Patients with recurrent, persistent or metastatic ovarian, primary peritoneal or fallopian tumor carcinoma

•Cohort B5
o Patients with head and neck squamous cell cancer

•Cohort B6:
o Patients with measureable TNBC
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Previous immediate or delayed hypersensitivity reaction or idiosyncrasy to the excipients.
•Active or prior autoimmune disease, with the following allowed exceptions:
o Vitiligo, autoimmune thyroiditis, or psoriasis (not requiring systemic treatment within 2 years), type I diabetes on stable insulin therapy or – in the view of the Investigator – resolved childhood asthma/atopy;
o Intermittent use of bronchodilators, inhaled steroids or local steroid injections including intra-articular injections;
o Hypothyroidism stabilized on HRT; and
o Celiac disease adequately controlled by diet alone.

Parts A and A-2 are not conducted in EU/EEA and, therefore, specific exclusion criteria are not described.

Part B:
•Cohort B1 and B7:
o Treatment other than anti-PD-1 and/or chemotherapy prior to treatment initiation or not recovered to CTCAE V5.0 Grade 1 or better from AE due to prior anti-PD-1 administration
•Cohort B2:
o Treatment other than anti-PD-1 or a platinum-based chemotherapy regimen recommended as first-line or second-line treatment by current NCCN treatment guidelines or not recovered to CTCAE V5.0 Grade 1 or better from AE due to first- or second-line treatment.
•Cohort B3:
o Any treatment other than a local standard-of-care first-line chemotherapy regimen or not recovered to CTCAE V5.0 Grade 1 or better from AE due to first-line treatment.
o Receipt of a PD-1, PD-L1, 4-1BB or CTLA-4 antibody or any other investigational biological drugs.
o EGFR tyrosine kinase activating mutations or ALK gene rearrangements.
•Cohort B4:
o Prior therapy with anti-PD-1, anti-PD-L1, anti-4-1BB or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways.
o Prior chemotherapy for any abdominal or pelvic tumor other than ovarian, fallopian tube, or primary peritoneal cancer within 3 years
•Cohort B5:
o Previous systemic drug therapy for their disease.
•Cohort B6:
o For subgroup 1:
-Treatment with PD-1 or PD-L1 antibody within 2 weeks or 5 half-lives of first dose of study drug, respectively.
-Has not recovered to CTCAE V5.0 Grade 1 or better from AE due to prior anti-PD-1 or anti-PD-1 antibody.
-Previous treatment with anti-CTLA-4 or anti-4-1BB antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways other than the PD-1/PD-L1 pathway
o For subgroup 2:
-Prior therapy with anti-PD-1, anti-PD-L1, anti-4-1BB or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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