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A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects with Solid Tumors
This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options.
Study details:
The study includes two parts, a dose escalation part (Part A) followed by a dose expansion part (Part B). Part A will estimate the maximum tolerated dose (MTD) in dose escalation cohorts in patients with advanced solid tumors for whom no standard therapy is available in order to establish the recommended dose for expansion (RDE). Successive cohorts of subjects will receive escalating doses of NST-628 orally once daily in 28-day cycles.
Bayesian Optimal Interval (BOIN) method will be used for dose escalation. Once MTD is reached or dose escalation is stopped prior to reaching MTD and provisional RDE selected, the provisional RDE level will be expanded. If warranted by dose/toxicity/anti-tumor activity observations, additional, lower dose level(s) may also be expanded.
Part B of the study will include up to 6 cohorts of approximately up to 30 subjects each with select MAPK pathway mutant solid tumors enrolled at the RDE in order to explore benefit from treatment as suggested by preclinical findings and will better define the safety profile of NST-628 at the RDE. Additional safety information gathered in Part B may be used to modify the dose recommended for future studies. The end of the study is the last visit of the last subject.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-04-09
Primary completion: 2028-11-01
Study completion finish: 2029-11-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06326411
Intervention or treatment
DRUG: NST-628
Conditions
- • Melanoma
- • NSCLC
- • Glioma
- • Solid Tumor, Adult
- • Oncology
- • MEK Mutation
- • RAF Gene Mutation
- • Ras (KRAS or NRAS) Gene Mutation
- • MAPK Pathway Gene Mutation
Find a site
Closest Location:
Scientia Clinical Research, Ltd
Research sites nearby
Select from list below to view details:
Scientia Clinical Research, Ltd
Rand, New South Wales, Australia
The Kinghorn Cancer Center, St. Vincent's Health Network
Sidney, New South Wales, Australia
Gallipoli Medical Research Centre- Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Southern Oncology Research Unit
Adelaide, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Part A Dose Escalation and Part B Dose Expansion
| DRUG: NST-628
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors | Adverse effects | Through study completion, an average of 1 year |
Part A: Determine the recommended dose for expansion of NST-628 | Dose limiting toxicities (DLTs) | The first 28 days of treatment (DLTs) |
Part B: Evaluate objective tumor response rate | Objective response per RECIST v. 1.1 or other response assessment tool standard for a given tumor type. | Through study completion, an average of 1 year |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Part A: Evaluate objective tumor response rate | Objective response per RECIST v. 1.1 or other response assessment tool standard for a given tumor type. | Through study completion, an average of 1 year |
Part A and B: Evaluate progression free survival (PFS) | PFS defined as the time to first occurrence of disease progression per RECIST v1.1 (or other response assessment tool standard for a given tumor type) or death | Through study completion, an average of 1 year |
Part A and B: Evaluate overall survival (OS) | Overall survival (OS) defined as the time to death | Through study completion, an average of 2 years |
Part A and B: Characterize the pharmacokinetics of NST-628 | NST-628 concentrations in plasma | Through study completion, an average of 1 year |
Frequently Asked Questions
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