Clinical trial NCT05478486: Assessment of Safety, Tolerability and PK Profile of MSP008-22 in Patients With Advanced Solid Tumours
Official title: A Single Ascending Dose, Phase I Trial to Assess Safety, Tolerability and Pharmacokinetic Profile of MSP008-22 in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: Single Ascending Dose
First in Man
FIM
SAD
MSP008
Phase 1
Lead sponsor: Godavari Biorefineries Limited
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: At least 3 patients will be enrolled at only one dose level and dosed with one only dose of MSP008-22. Each dosed patient will be evaluated for 72.00 hours post-dose for primary and secondary endpoints (i) If there are no AE or abnormal laboratory results experienced by these three patients, the trial will move to the next dose level (next cohort of 3 different patients), (ii) If in a single Cohort, any one patient experiences any Dose Limiting Toxicity, additional 3 patients will be dosed at the same dose level, (iii) If in a single Cohort, more than 33% of the patients experience Dose Limiting Toxicity, the Cohort will be stopped, and further dose escalation will not happen in the study.
Primary purpose: BASIC_SCIENCE

Brief summary: This is the 'first-in-human' clinical trial of the Investigational Medicinal Product (IMP), Tablet formulation for Oral dosing of MSP008-22, a molecule (new chemical entity) with anticancer properties.

Detailed description: This Single Ascending Dose (SAD) clinical trial is designed to evaluate the safety and tolerability of single oral ascending doses of the IMP in patients with Stage IV of advanced solid tumours including but not limited to Breast cancer including Triple-negative breast cancer, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer).

The trial will also assess the pharmacokinetic (PK) profile of MSP008-22 in humans.

The safety, tolerability and PK data from this trial will determine the safety of MSP008-22 for dosing in humans in further clinical trials.

As MSP008-22 has shown efficacy in in vitro studies against various cancer cell lines and in prostate and breast cancer cell lines in xenograft studies, the first in human trial of MSP008-22 is planned in patients of 'Stage-IV of Advanced Solid Tumours (Breast cancer including Triple-negative breast cancer, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer and other advanced solid tumors).

Eligibility criteria: Inclusion Criteria:

1. Adult patients, willing to provide written informed consent and willing to comply to trial requirements, in age range of 18-60 years (both inclusive), with stage IV - metastatic or unresectable Solid tumours (Breast cancer including TNBC, Ovarian cancer, Prostate cancer, Head and Neck squamous cell cancer).
2. Adequate bone marrow function and hepatic \& Renal function
3. Has a performance status of 0 to 1 on Eastern cooperative Oncology Group (ECOG) Performance Scale and a Karnofsky Performance Status (KPS) ≥ 70
4. Adequate laboratory parameters for Haemoglobin levels, Absolute Neutrophil Count (ANC), Platelets, AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement/ metastases), ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN if known liver involvement/ metastases), Total bilirubin ≤ 1.5 x ULN (unless diagnosis of Gilbert's syndrome in which case \< 3.0 times ULN), and Serum creatinine ≤ 1.5 x ULN or estimated GFR ≥ 60 mL/min
5. If male, must agree to use contraception and refrain from donating sperm during the treatment period and for ≥120 days after last dose of trial treatment.
6. If female, is not pregnant or breastfeeding, and agrees to use contraception during the treatment period and for ≥120 days after last dose of trial treatment.

Exclusion Criteria:

1. Patients who have been treated with most recent radiotherapy, immunotherapy, chemotherapy or investigational drugs within ≤10 days or 5 half-lives (whichever is shorter) from enrolment (screening), and/or who have any unresolved NCI Common Terminology Criteria of Adverse Events (CTCAE) v5.0 \> Grade 1 treatment-related side effect, with the exceptions of alopecia
2. Major surgery (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days.
3. Primary immunodeficiency affecting cellular immunity and active autoimmune disease with the exception of Type I Diabetes Mellitus, hypothyroidism requiring hormone replacement only, an autoimmune dermatologic condition that is managed without systemic therapy, or autoimmune arthritis that is managed without systemic therapy or documented history of autoimmune syndrome or disease.
4. Chronic medical condition that requires chronic steroid therapy or immunosuppressive medication.
5. Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: 10 days post dose
measure: Incidence of dose-limiting toxicities (DLTs)
timeFrame: 10 days post-dose
measure: Incidence of Treatment Emergent adverse events (TEAE); % of patients who experience at least 1 Treatment Emergent Adverse Event (TEAE); % of patients who discontinue due to TEAE(s).
timeFrame: 30 days post-dose
Secondary outcomes:
measure: Plasma Cmax
timeFrame: 72 hours post dose
measure: Plasma AUClast
timeFrame: 72 hours post dose
measure: Plasma AUCinfinity
timeFrame: 72 hours post dose
measure: plasma tmax
timeFrame: 72 hours post dose
measure: Plasma t1/2
timeFrame: 72 hours post dose
measure: CL/F
timeFrame: 72 hours post dose
measure: Vz/F
timeFrame: 72 hours post dose
measure: Ae
timeFrame: 72 hours post dose
measure: Ae %dose
timeFrame: 72 hours post dose
measure: CLr
timeFrame: 72 hours post dose
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) of TATA Memorial Centre
state: Maharashtra
Study officials:
affiliation: Clinexel Life Sciences Pvt. Limited
name: Deepa Arora, MD
role: STUDY_DIRECTOR
References: