Advanced Solid TumorPhase 1NCT05478486
Assessment of Safety, Tolerability and PK Profile of MSP008-22 in Patients With Advanced Solid Tumours
A Phase 1 study testing MSP008-22 in people with Advanced Solid Tumor, run by Godavari Biorefineries Limited at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- MSP008-22
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2023to 23 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
- Adequate bone marrow function and hepatic \& Renal function
- Has a performance status of 0 to 1 on Eastern cooperative Oncology Group (ECOG) Performance Scale and a Karnofsky Performance Status (KPS) ≥ 70
- 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
- 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.
- 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.
Who cannot join
- 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
- Major surgery (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days.
- 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.
- Chronic medical condition that requires chronic steroid therapy or immunosuppressive medication.
- Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
Trial locations and contacts
1 site in 1 country.
India1 site
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) of TATA Memorial Centre
Navi Mumbai, Maharashtra, 410210
About this study
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
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.
Read the 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).
- Conditions
- Advanced Solid Tumor
- Being tested
- MSP008-22
- Keywords
- Single Ascending Dose, First in Man, FIM, SAD, MSP008, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSP008-22Drug
It is single group assignment interventional model in this clinical trial, consisting of 5 cohorts of 3 patients in each, to be enrolled such that there exists an overall gender balance for the entire trial and to also ensure including minimum five (5) patients of TNBC and minimum five (5) male patients.
The trial will be initiated with dosing of a cohort of 03 patient with the Safe starting dose for MSP008-22. Dosing of the patients for the next higher dose cohort will initiate only after: (i) All 03 patients have been recruited in the lower dose Cohort and if a repeat Cohort at this dose level is recommended, another 03 patients have been recruited at same dose level (ii) all dosed patients have completed the allocated study cohort duration, (iii) safety and pharmacokinetic results have been reviewed by the Independent Dose Escalation Committee (DEC) and approved for dose escalation to next cohort.
| Study group | Role | What they receive |
|---|---|---|
| MSP008-22 treatment arm | Experimental | Oral Escalating doses of MSP008-22- total five doses, each in form of a single dose oral formulation/tablet.
Each trial participant will receive only one single oral dose of 05 identified dose levels of MSP008-22. Intra-patient dose escalation will not be carried out Receives: Drug: MSP008-22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
to assess Tolerability of MSP008-22 in Human
Measured: 10 days post dose
Incidence of dose-limiting toxicities (DLTs)
to assess Safety of MSP008-22 in Human
Measured: 10 days post-dose
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).
to assess Safety of MSP008-22 in Human
Measured: 30 days post-dose
Secondary outcomes (10)
Plasma Cmax
(maximum measured concentration of MSP008-22 in plasma)
Measured: 72 hours post dose
Plasma AUClast
(area under the plasma concentration time curve of MSP008-22 from hour 0 to last sample with measurable plasma concentrations)
Measured: 72 hours post dose
Plasma AUCinfinity
(area under the concentration-time curve of MSP008-22 in plasma over the time interval from 0 extrapolated to infinity)
Measured: 72 hours post dose
plasma tmax
(time from dosing to maximum measured concentration of MSP008-22 in plasma)
Measured: 72 hours post dose
Plasma t1/2
(terminal half-life of MSP008-22 in plasma)
Measured: 72 hours post dose
CL/F
(total clearance of MSP008-22 in plasma after administration estimated using formula)
Measured: 72 hours post dose
Vz/F
(apparent volume of distribution of MSP008-22 during the terminal phase following administration, estimated using formula)
Measured: 72 hours post dose
Ae
(the total amount of MSP008-22 excreted in urine)
Measured: 72 hours post dose
Ae %dose
(the percent of MSP008-22 recovered in urine)
Measured: 72 hours post dose
CLr
(and the apparent renal clearance of MSP008-22)
Measured: 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Feb 2023
- Primary completion23 Jan 2026
- Study completion23 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Godavari Biorefineries Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepa Arora, MD, Study director, Clinexel Life Sciences Pvt. Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478486
- Sponsor's protocol ID
- Clinexel-GBL-002
- Other IDs
- CTRI/2022/06/043504
- Status last verified
- Feb 2026
- First submitted
- 21 Jul 2022
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05478486
- Acronym / sponsor ID
- Clinexel-GBL-002
- Conditions
- Advanced Solid Tumor
- Keywords
- Single Ascending Dose, First in Man, FIM, SAD, MSP008, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Godavari Biorefineries LimitedUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 23 Jan 2026 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| MSP008-22 treatment arm | Experimental | Drug: MSP008-22Oral Escalating doses of MSP008-22- total five doses, each in form of a single dose oral formulation/tablet. Each trial participant will receive only one single oral dose of 05 identified dose levels of MSP008-22. Intra-patient dose escalation will not be carried out |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
- Adequate bone marrow function and hepatic \& Renal function
- Has a performance status of 0 to 1 on Eastern cooperative Oncology Group (ECOG) Performance Scale and a Karnofsky Performance Status (KPS) ≥ 70
- 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
- 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.
Key exclusion criteria (5 listed)
- 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
- Major surgery (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days.
- 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.
- Chronic medical condition that requires chronic steroid therapy or immunosuppressive medication.
- Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSP008-22It is single group assignment interventional model in this clinical trial, consisting of 5 cohorts of 3 patients in each, to be enrolled such that there exists an overall gender balance for the entire trial and to also ensure including minimum five (5) patients of TNBC and minimum five (5) male patients. The trial will be initiated with dosing of a cohort of 03 patient with the Safe starting dose for MSP008-22. Dosing of the patients for the next higher dose cohort will initiate only after: (i) All 03 patients have been recruited in the lower dose Cohort and if a repeat Cohort at this dose level is recommended, another 03 patients have been recruited at same dose level (ii) all dosed patients have completed the allocated study cohort duration, (iii) safety and pharmacokinetic results have been reviewed by the Independent Dose Escalation Committee (DEC) and approved for dose escalation to next cohort. | Drug | MSP008-22 treatment arm |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 10 days post dose
to assess Tolerability of MSP008-22 in Human
Incidence of dose-limiting toxicities (DLTs)
Time frame: 10 days post-dose
to assess Safety of MSP008-22 in Human
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).
Time frame: 30 days post-dose
to assess Safety of MSP008-22 in Human
10 secondary outcomes
Plasma Cmax
Time frame: 72 hours post dose
Plasma AUClast
Time frame: 72 hours post dose
Plasma AUCinfinity
Time frame: 72 hours post dose
plasma tmax
Time frame: 72 hours post dose
Plasma t1/2
Time frame: 72 hours post dose
CL/F
Time frame: 72 hours post dose
Vz/F
Time frame: 72 hours post dose
Ae
Time frame: 72 hours post dose
Ae %dose
Time frame: 72 hours post dose
CLr
Time frame: 72 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepa Arora, MD study director
Clinexel Life Sciences Pvt. Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSP008-22 in people with Advanced Solid Tumor, run by Godavari Biorefineries Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 10 days post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.