Health Condition 1: C069- Malignant neoplasm of mouth, unspecified
Conditions
Interventions
Intervention1: AB001 400 mg: Drug : AB001
Dose: 400 mg
Dosage form: Tablet
Frequency : twice daily
Duration: 126 days
Follow up : Day 140
Control Intervention1: chemotherapy with SOC: As per the
Sponsors
Vopec Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide voluntary informed consent and comply with protocol requirements. 2. Age 18 to 65 years. 3. Patients with advanced Cancer are not amenable to surgical therapy. 4. Patients with PD-L1 gene expression and Tumor proportion score (TPS) of greater than 1percent. Also, Interferon gamma is direct measurable indicator for PDL-1 levels in plasma. 5. Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. 6. Patients must have measurable disease on radiological CT / MRI / PET scan imaging to monitor treatment response. Measurable disease, as defined by RECIST v1.1. 7. Life expectancy greater than 24 weeks. Patients should be willing to undergo all treatment-related procedures and investigations. 8. Women of child bearing potential must agree to either use a contraceptive method or to remain abstinent during the treatment period and for at least 3 months after the last dose of the study drug. 9. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 10. Ability to swallow oral medications (tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. 11. There is no history of addiction to any recreational drug or drug dependence. Non-smokers and non-alcoholics. 12. Demonstrate adequate organ and bone marrow function. All screening laboratories should be performed within 14 days of treatment initiation. 13. The patient should be willing and ready for a PET scan, Blood Investigations, PK, ECG, and follow-up. 14. The patient is willing to take and tolerate cytotoxic drugs. 15. Patients must have discontinued chemotherapy, immunotherapy, or other investigational agents used in the adjuvant setting greater than or equal to 4 weeks prior to the trial and recovered from adverse events due to those agents; mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study; patients must have discontinued radiation therapy greater than or equal to to 2 weeks prior to entering the study and recovered from any adverse events associated with treatment; prior surgery must be greater than or equal 4 weeks from prior to entering the study and patients must be fully recovered from post-surgical complications. 16. Participants must have normal organ and marrow function as defined below: a. Absolute neutrophil counts greater than or equal 1,500/mL b. Platelets greater than or equal to 100,000/Ml c. Haemoglobin greater than or equal 9.0 g/dl d. Total bilirubin lower than or equal 1.5 institutional upper limit of normal (ULN) (or lower than or equal 2.0 x ULN in patients with documented Gilberts Syndrome) e. AST(SGOT)/ALT(SGPT) lower than or equal 2.5 institutional ULN or lower than or equal 5 institutional ULN for participants with documented liver metastases f. Serum creatinine lower than or equal 1.5 institutional ULN or creatinine clearance greater than or equal 45 mL/min/ 1.73m2 for participants with creatinine levels above institutional ULN g. The participant must be capable of understanding and compl
Exclusion criteria
Exclusion criteria: 1. Patient above 65 years of age. 2. Concurrent enrollment in another clinical study, unless it is an observational (non- interventional) clinical study or the follow-up period of an interventional study. 3. Patients with PD-L1 gene expression and Tumor proportion score (TPS) of less than 1percent. No measurable Interferon gamma in plasma is detected. 4. Pregnant or lactating women or intending to become pregnant during the study. 5. Life-threatening comorbidities such as HIV, HPV, HBV, HCV, Tuberculosis, CHF, Impaired Hepatic or Renal Function, or any psychological deficits, etc. 6. Patient undertaking any radiotherapy or immunotherapy will be excluded from the study 7. Active infections including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBs Ag] result), hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBs Ag) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if the polymerase chain reaction is negative for HCV ribonucleic acid (RNA). 8. Known CNS diseases (Alzheimers disease, Parkinsons disease, Bells palsy, Cerebral Palsy, Epilepsy, Motor Neuron disease (MND), Multiple Sclerosis (MS), Neurofibromatosis. Sciatica and Shingles) except for treated asymptomatic CNS metastases. 9. Uncontrolled pleural effusion, pericardial effusion, or ascites 10. Uncontrolled tumor-related pain. 11. Patients are not suitable for study, as per the investigators opinion. Significant cardiovascular diseases, such as New York Heart Association (NYHA) as Standard of cardiac disease (Class II or greater), MI within 3 months prior to randomization, unstable arrhythmias, or unstable angina. 12. Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis. 13. History of autoimmune disease. 14. Prior allogeneic stem cell or solid organ transplantation. Poor peripheral venous access. 15. Any other medical condition or uncontrolled systemic disease (e.g., cardiovascular disease, hypertension, diabetes mellitus, etc.) that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study, including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements. 16. Patient has any prior treatment with other treatments without adequate washout periods as defined in the Protocol. 17. The patient must not have received any live vaccine within 30 days prior to randomization while participating in the study and for 4 weeks (28 days) after the last dose of protocol treatment; live vaccines include but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine patients are permitted to receive inactivated vaccines and any non-live vaccines including those for seasonal influenza and coronavirus disease 19 (COVID-19) (Note: intranasal influenza vaccines, such as Flu-Mist are live attenua
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from the date of randomization until the date of objective radiological disease progression according to Investigator assessment using RECIST 1.1 or death (by any cause in the absence of progression) Percentage of patients with an Investigator-assessed response of CR or PR after randomizationTimepoint: Day 0 to Day 126 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy AB001 as monotherapy in comparison with chemotherapy, AB001 and combined chemotherapy in comparison with chemotherapy alone in terms of OS and DoRTimepoint: Base line to end of the study;To assess the PK and Metabolites of AB001Timepoint: Base line, Day 42, Day 84 and Day 126;To assess disease-related symptoms and HRQoL in patients treated with AB001 as monotherapy in comparison with chemotherapy, AB001 and combined chemotherapy in comparison with chemotherapy aloneTimepoint: Day 0 to end of the study;To assess the genetic profiling of AB001 as monotherapy in comparison with chemotherapy, AB001 and combined chemotherapy in comparison with chemotherapy alone (Investigator-assessed)Timepoint: Day 0 to end of the study;To assess the safety of AB001 as monotherapy in comparison with chemotherapy, AB001 and combined chemotherapy in comparison with chemotherapy alone in subjects with metastatic cancer using the NCI CTCAE V5.0.Timepoint: Day 0 to end of the study;To assess blood and tissue samples at baseline (for baseline, on treatment, and at the end of the treatment) for immune-related markers, mRNA/protein signatures, and DNA mutations/signatures that are predictive of clinical benefit to AB001 as monotherapy in comparison with AB001 combined chemotherapy and with chemotherapy alone.Timepoint: Screening/Baseline, Day 42,Day 63,Day 126 and follow up visit (Day 140) | — |
Countries
India
Contacts
Public ContactRamakrishnan Karnan
Vopec Pharmaceutical Pvt Ltd
Outcome results
None listed