Anti-PD1 2C12 in adult patients with advanced non-small cell lung cancer and unresectable or metastatic melanoma. Phase I-II

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

A phase I-II, multicenter, open-label, non-randomized, parallel-cohort clinical trial to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of the Anti-PD1 monoclonal antibody 2C12 in adult patients with advanced non-small cell lung cancer in second-line setting and unresectable or metastatic melanoma. PALOMA study.

Acronym of Scientific Title:

PALOMA study

Secondary indentifying numbers:

C31 PCL-0011

Issuing authority of the secondary identifying numbers:

Center for Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center for Molecular Immunology (CIM), Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Yoanna

Midle name:

Ivette

Last name:

Flores Vega

Medical Specialty :

Second-degree specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal address:

29th Street between D and F, Vedado, Revolution Square

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78369209

Email address:

yflores@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Hermanos Ameijeiras Clinical Surgical Hospital (HHA), Dr. Iraida Caballero Aguirrechu (Second-Degree Specialist in Oncology)

Villa Clara, Celestino Hernández Robau University Hospital, Dr. Eduardo Ibáñez Carrillo (Second-Degree Specialist in Oncology)

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

05/01/2026

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Advanced non-small cell lung cancer in second-line treatment and unresectable or metastatic melanoma

Health condition(s) code:

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Melanoma

Nevi and Melanomas

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Intervention(s):

Anti-PD1 2C12 monoclonal antibody; 200 mg every three weeks (intravenous infusion) until disease progression or unacceptable toxicity occurs

Intervention code:

Antibodies, Monoclonal, Humanized

Antibodies, Monoclonal

Drug Therapy

Antineoplastic Agents

Administration, Intravenous

Intervention keyword:

Anticuerpo monoclonal Anti-PD1 2C12

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Objective response rate (ORR) (RECIST 1.1 criteria: complete or partial response). Measurement time: at enrollment, week 16, and subsequently every 12 weeks until 24 months or patient death. Grade 3-5 adverse events with a proven causal relationship (definite, highly probable, or probable) to product administration. Measurement time: up to 30 days after the last dose of treatment (maximum 24 months).

Key secondary outcomes:

Adverse events (AEs). Measurement time: up to 30 days after the last dose of treatment received and up to a maximum of 24 months - Occurrence of any AE in the subject (yes/no). - Description of the AE (Name of the adverse event). - Duration of the AE (Difference in dates between the start and end of the event) - Intensity of the AE (Mild, Moderate, Severe, Life-threatening or disabling AE, Fatal AE) - Severity of the AE (Serious, Not serious) - Attitude towards the study treatment (no change in dose, temporary or permanent interruption of the study treatment) - Outcome of the AE (recovered/resolved, improving/in resolution, persistent/unresolved, with sequelae requiring treatment) -Causality (1.Definite, 2.Very Probable, 3.Probable, 4.Possible, 5.Not related, 6.Unknown) -Antibodies against the monoclonal antibody Anti-PD1 2C12 (yes/no). Measurement time: prior to the start of treatment and every six weeks while the treatment is maintained. Pharmacokinetic parameters (values estimated using the Monolix system, SAEM algorithm combined with Monte Carlo code with a sparse data design in blocks of 3, with 4 repetitions per block where each patient will have 4 extractions). Measurement time: baseline (first hour before infusion), end of infusion (at 60 minutes), after infusion at 6 hours, 24 hours, 48 hours, 168 hours (one week), 336 hours (two weeks), 504 hours (three weeks, coincides with the baseline sample of the next cycle): - Area under the curve (AUC) - Maximum concentration (Cmax) - Time to maximum concentration (Tmax) - Minimum concentration - Elimination half-life (t1/2) - Plasma clearance (CL) - Volume of distribution (Vd) Overall Survival (OS) (Time from the date of patient inclusion in the study until death, regardless of cause, or until the date of last news). Measurement time: 24 months. Progression-free survival (PFS) (Time from patient inclusion date to the date considered disease progression or death from any cause). Measurement time: 24 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

• Patients eligible for treatment with the monoclonal antibody Anti-PD1 2C12 who meet the diagnostic criteria described. • Patients ≥18 years of age and of any sex. • Patients with NSCLC who are progressing after receiving at least one platinum-doublet-based chemotherapy regimen. • Patients with NSCLC who are immunotherapy-naïve, using antibodies against immune checkpoints such as atezolizumab or other • Patients who provide informed consent to participate in the research. • Patients with measurable disease according to RECIST 1.1. • Patients with a life expectancy of at least three months. • Patients with an ECOG performance status ≤ 2 according to the Eastern Cooperative Oncology Group (ECOG) scale. • Patients with no history of prior malignancy, with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix. • Patients with adequate organ function as indicated by the following laboratory values: Parameter Value Absolute neutrophil count: ≥ 1500/µL Platelets: ≥ 100,000/µL Hemoglobin: ≥ 9 g/dL Creatinine: ≤ 1.5 times the upper limit of normal (ULN) according to the research site's reference parameters Total Bilirubin: ≤ 1.5 times ULN AST (SGOT) and ALT (SGPT)*: ≤ 3 times ULN* ALT and AST ≤ 5 times ULN will be accepted in cases of liver metastases. *ALT = alanine aminotransferase, AST = aspartate aminotransferase. TSH: Within normal limits. Note: If TSH is not within normal limits at baseline, the participant may be eligible if free T3 and T4 are within normal limits. A TSH < 10 mIU/L will be accepted in patients with known, controlled hypothyroidism. • Patients of childbearing potential must have a negative pregnancy test at the time of screening. • Patients of childbearing potential must be willing to use adequate contraception throughout the study.

Exclusion criteria:

• Patients with NSCLC without PD-L1 expression or <1%. • Patients with NSCLC who have a documented EGFR sensitizing (activating) mutation or ALK rearrangement, documented in their medical record. • Pregnant or breastfeeding patients. • Patients receiving other investigational medications. • Patients receiving chronic steroid therapy or doses ≥10 mg/day of prednisone or equivalent within the 14 days prior to initiating treatment. • Patients with central nervous system metastases and/or carcinomatous meningitis. • Patients with active autoimmune disease requiring systemic treatment within the past two years (e.g., with disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. • Patients who have undergone an allogeneic solid organ/tissue transplant. • Patients with interstitial lung disease (ILD) or a history of pneumonitis requiring oral or intravenous steroids. • Patients with an active infection requiring intravenous systemic therapy. • In patients with symptoms and signs of hepatitis B, hepatitis C, or tuberculosis infection, active infection should be ruled out. • Patients with a history of psychiatric disorders or substance abuse.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

1-2

Target sample size:

122

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yoanna

Middle Name:

Ivette

Last Name:

Flores Vega

Specialty:

Second-degree specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology

Postal Address:

29th Street between D and F, Vedado, Plaza de la Revolución

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+(53) 78369209

Email :

yflores@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Yanelda

Middle Name:

de los Angeles

Last Name:

Garcia Vega

Specialty:

Biochemistry

Affiliation:

Center for Molecular Immunology (CIM)

Postal Address:

216th Street, Corner of 15th Street, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+(53) 72717933 ext. 3397

Email :

yaneldag@cim.sld.cu

taniac@cim.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

National Institute of Oncology and Radiobiology (INOR)

Celestino Hernandez Hospital

Hermanos Ameijieras Clinical Surgery Hospital

Status of evaluation:

Approved

In evaluation

Status of evaluation date of Ethic Committee:

07/11/2025

12/11/2025

Postal address of Ethic Committee :

F # 710 e/ 29 and Final, Plaza, Havana, PB:10400, Cuba

Cuba No. 564 b/ Barcelona and Hospital. Santa Clara, Villa Clara. PB. 50100, Cuba

San Lazaro 701 corner to Belascoain, Havana, ZC 10300, Cuba

Telephone:

+53-78388663

+53-42279401

+53-78761000

Correo electrónico:

inor@infomed.sld.cu

direccion@hchr.vcl.sld.cu

hha@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

29/12/2028

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000463

Date of Registration in Primary Registry:

17/11/2025

Record Verification Date:

2025/11/17

Next update date:

2026/11/17

Link to the spanish version:

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Anti-PD1 2C12 in adult patients with advanced non-small cell lung cancer and unresectable or metastatic melanoma. Phase I-II

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