A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors (NCT05501912) | Clinical Trial Compass
TerminatedPhase 1
A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors
Stopped: Adjustment of the applicant's research and development strategy
China20 participantsStarted 2022-09-01
Plain-language summary
This is a Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in patients with BRAF V600-Mutant advanced solid tumors. This study consists of two stages: dose escalation and dose expansion. During the dose escalation stage, a classic "3+3" design will be used to guide dose escalation to determine MTD and RP2D. The dose expansion stage will be initiated at the MTD or the optimal dose determined by the Safety Monitoring Committee (SMC ) as a fixed dose level (MTD or the optimal dose needs to be reviewed by the SMC and subjects are safe and tolerable at that dose level).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subjects who are able to understand and voluntarily sign informed consent forms (ICFs).
✓. Male and female subjects at the age of ≥18 and ≤80 at the time of screening.
✓. Patients with histologically or cytologically-confirmed, locally advanced, or metastatic solid tumors with (a) failure of prior standard therapy, (b) no standard therapy available, or (c) for whom standard therapy is not applicable considered by the patient or treating physician. There is no limit to the number of prior treatment lines. Subjects who were previously treated with BRAF and/or MEK inhibitors are allowed to be enrolled in this study.
✓. Documentation of positive BRAF V600 mutation is required for enrollment (the blood BRAF V600 test report is received at the dose-escalation stage). Representative tumor specimens suitable for confirmation of BRAF V600 mutations by retrospective analysis are required (for dose-expansion stage only). It is recommended to provide sufficient fresh/archived tumor tissue samples (formalin-fixed paraffin-embedded tumor specimens \[preferred\]) or 5-10 available unstained sections of good quality for verification of BRAF V600 mutation status at the central laboratory. For any subject who is unable to provide suitable and adequate tumor specimens, re-biopsy (with controllable safety) can be performed in a non-mandatory manner if it is feasible as assessed by the investigator and the subject gives informed consent; if re-biopsy is impossible or refused by the subject, his/her eligibility for enrollment shall be confirmed by both the investigator and the sponsor.
✓
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: From the enrollment of subjects to the end of Cycle 1 (each cycle is 28 days) or up to treatment discontinuation, whichever occurs first, assessed up to 33 days.
2
Recommended Phase 2 Dose (RP2D)
Timeframe: From the enrollment of subjects to the end of Cycle 1 (each cycle is 28 days) or up to treatment discontinuation, whichever occurs first, assessed up to 33 days.
3
Dose Limiting Toxicity (DLT)
Timeframe: Single dose PK observation period (5 days) and Cycle 1 (28 days) (33 days in total)
4
The incidence of treatment-related adverse events AE(s)
Timeframe: Up to 28 days from treatment discontinuation
5
Number of participants with abnormal laboratory values
Timeframe: Up to 28 days from treatment discontinuation
6
Number of participants with abnormal vital signs
Timeframe: Up to 28 days from treatment discontinuation
7
Number of participants with abnormal physical examinations
Timeframe: Up to 28 days from treatment discontinuation
. Patients with BMs/primary intracranial solid tumors that are asymptomatic, or that are symptomatic but on a stable or decreasing dose of steroids for at least 2 weeks are eligible for enrollment. The specific criteria are as follows:
✓. Subjects who only have evaluable lesions are allowed to be included for the dose escalation stage. They must have at least one measurable lesion (intracranial or extracranial) as defined by RECIST V1.1 criteria or modified RECIST v1.1 for subjects with BMs or the RANO criteria for subjects with primary intracranial solid tumors during screening at the dose expansion stage. Lesions previously treated with radiotherapy shall not be deemed as target lesions unless significant progression as shown on imaging.
✓. ECOG score of 0 or 1 or Karnofsky PS score of ≥ 70.
✓. Life expectancy \> 3 months.
Exclusion criteria
✕. Women who are pregnant or breast-feeding.
✕. Subjects with history of neoplasm malignant within 5 years prior to screening, excluding cured carcinoma in situ of cervix, non-melanoma skin cancer, localized prostate cancer and other tumors/cancers that have undergone radical treatment and shown no signs of disease for at least 3 years (This exclusion criterion is only applicable for dose expansion stage. For the dose escalation stage, any patient with double primary malignant solid tumors who can indeed benefit from this study as confirmed by the investigator is eligible for the screening; however, those with any combined primary hematological malignant tumor shall be excluded).
✕. Subjects with intracranial hypertension or associated risks (e.g., intracranial infection, intracranial hemorrhage).
✕. Subjects with clinically uncontrolled pleural effusion, pericardial effusion, or ascites who, in the judgement of the investigator, are not eligible for enrollment.
✕. Subjects with cancerous meningitis (leptomeningeal disease \[LMD\]).
✕. Subjects with history of symptomatic stroke within 6 months prior to initiation of study treatment.
✕. Subjects with epileptic seizure within 14 days prior to initiation of study treatment.
✕. Impaired cardiac function or clinically significant cardiovascular disorder, including but not limited to any of the following:
8
Number of participants with abnormal ophthalmic evaluation
Timeframe: Up to 28 days from treatment discontinuation
9
Number of participants with abnormal ECG
Timeframe: Up to 28 days from treatment discontinuation
10
Number of participants with abnormal ECOG
Timeframe: Up to 28 days from treatment discontinuation
11
Number of participants with abnormal Karnofsky PS
Timeframe: Up to 28 days from treatment discontinuation