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Advanced Solid TumorPhase 1NCT05501912

A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors

A Phase 1 study testing ABM-1310 in people with Advanced Solid Tumor and BRAF V600 Mutation, run by ABM Therapeutics Shanghai Company Limited at 10 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Solid Tumor, BRAF V600 Mutation
What is being tested?
ABM-1310
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
10 sitesChina
Study dates
1 Sep 2022to 17 Jun 2024
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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 with inactive and asymptomatic BMs/primary intracranial solid tumors;
Show all 28Show fewer
  • Subjects who have active, mild neurological signs and symptoms currently requiring no therapy with steroids, and have no history of epileptic seizure within 2 weeks prior to initiation of treatment;
  • Subjects who have active, neurological signs and symptoms and were on a stable or gradually reducing dose up to 4 mg of dexamethasone (or equivalent) per day within 2 weeks prior to initiation of treatment;
  • 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.
  • o For BMs from solid tumors;At least one measurable extracranial lesion is required if the longest diameter of the intracranial lesion is less than 0.5 cm (for dose expansion stage only).Subjects with measurable intracranial lesions of 0.5-3 cm in longest diameter (the lower limit of the longest diameter is defined according to the modified RECIST V1.1 criteria are allowed for the study, and measurable extracranial lesions are not required.Subjects with intracranial lesions > 3 cm in longest diameter are not eligible for the study.
  • ECOG score of 0 or 1 or Karnofsky PS score of ≥ 70.
  • Life expectancy > 3 months.
  • Adequate organ function (no blood transfusion and no use of granulocyte colony-stimulating factor, or other hematopoietic stimulator support within 2 weeks before the first administration of the study drug) confirmed as evidenced by:
  • Absolute Neutrophil Count (ANC) ≥ 1.5×10^9/L;
  • Hemoglobin (Hgb) ≥ 90 g/dl;
  • Platelets (Plt) ≥ 75×10^9/L;
  • AST/ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN if liver metastases are present;
  • Bilirubin total ≤ 1.5 x ULN, or bilirubin direct < ULN for patients with bilirubin total levels >1.5 ULN;
  • Serum creatinine < 1.5 x ULN or creatinine clearance > 50 mL/min (as calculated via Cockcroft-Gault formula based on the actual body weight of the subject ;
  • International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN for subjects not receiving anticoagulant therapy, and INR is maintained within the standard range of treatment prior to starting study drug for subjects receiving anticoagulant therapy.
  • Hepatitis B virus surface antigen (HBsAg) is negative, or HBsAg is positive but HBV DNA titer is below the lower limit of positive detection of the participating site at screening.
  • o HBsAg-positive or HBV-DNA positive subjects shall be managed according to institutional guidelines (anti-HBV therapy, where appropriate, and close monitoring of liver function and HBV-DNA replication shall be performed).
  • Negative hepatitis C virus (HCV) antibody test or positive HCV antibody test at the time of screening followed by a negative HCV-RNA test result.
  • o HCV-RNA testing is performed only for subjects with a positive HCV antibody test result.
  • Negative HIV test result at the time of screening.
  • All pre-menopausal women and women with menolipsis < 12 months should have a negative pregnancy test result within 7 days before starting study treatment.
  • Must agree to take sufficient contraceptive methods before initiation of study treatment, during the study, and for at least 3 months after the last dose of the study drug.
  • Subjects who are able to swallow a capsule in whole (without chewing, crushing, or opening).

Who cannot join

  • 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.
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  • 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:
  • Left Ventricular Ejection Fraction (LVEF) < 50% as determined via cardiac ultrasound.
  • Long QT syndrome congenital.
  • QTcF (as corrected via Fridericia formula) ≥ 450 ms (males) or 470 ms (females) at screening.
  • Second-degree type II AV block or third-degree AV block.
  • Unstable angina pectoris within 6 months prior to starting study drug.
  • Acute myocardial infarction within 6 months prior to starting study drug.
  • New York Heart Association (NYHA) Class II or higher heart failure within 6 months prior to study treatment.
  • Ventricular arrhythmias > Grade 2 within 6 months prior to study treatment.
  • Poorly controlled hypertension as defined as systolic blood pressure of >160 mmHg or diastolic blood pressure of > 100 mmHg despite use of antihypertensive medications.
  • Combined with any pulmonary embolism, or presence of any serious deep vein thrombosis on lower extremities that require medical interventions such as vena cava filter insertion at the screening .
  • Poorly controlled diabetes (fasting glucose > 10 mmol/L or Glycosylated Haemoglobin (HbA1c) > 8%) despite standard drug therapy.
  • Subjects with:
  • CTCAE grade 2 or higher unresolved diarrhea, or
  • Impaired gastrointestinal (GI) function or GI diseases that may significantly alter the absorption of ABM-1310 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Previous or current, Grade 2 or higher eye disorder, such as retinal vein occlusion (RVO).
  • Severe chronic or active infections requiring intravenous anti-infective therapy within 2 weeks prior to study treatment, including but not limited infectious complications leading to hospitalization, bacteremia, severe pneumonia, or active tuberculosis.
  • o Subjects with local fungal infections of skin or nails are allowed for enrollment. Subjects receiving prophylactic antibiotics (e.g., to prevent urinary tract infections or exacerbations of chronic obstructive pulmonary disease) are eligible for study (except for antibiotics prohibited by the protocol).
  • Subjects with solid organ or hematopoietic stem cell transplant within the past 5 years.
  • Patients receiving chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to study treatment, including the followings:
  • Receiving nitrosourea or mitomycin-C within 6 weeks prior to study treatment.
  • Receiving fluorouracil or small molecule targeted drug therapy within 5 half-lives or 2 weeks (whichever is longer) prior to study treatment.
  • Receiving Chinese herbal or patent medicine within 2 weeks prior to study treatment for anti-tumor indications.
  • Subjects receiving radical radiotherapy or radiotherapy to more than 30% of bone marrow or whole-brain radiotherapy (WBRT) within 4 weeks or palliative radiotherapy for non-target lesions with the aim of relieving symptoms (e.g., bone radiotherapy for pain relief) or stereotactic radiosurgery (including SRS) within 2 weeks prior to starting study drug.
  • Adverse reactions resulted from prior antitumor therapy that have not resolved to baseline or ≤ grade 1 (CTCAE 5.0), except alopecia or ≤ grade 2 peripheral neuropathy, hypothyroidism stabilized by hormone replacement therapy, etc.
  • Subjects who have undergone major surgery within 4 weeks prior to study treatment or who have not recovered from side effects of such therapy or who are expected to undergo major surgery during study treatment. However, a minimum of 2 weeks recovery time from major surgery to starting study drug is required if in investigator's opinion the patient has recovered from such major surgery.
  • Subjects currently receiving therapeutic doses of warfarin sodium or any other coumarin-derivative anticoagulants.
  • Subjects who have received systemic corticosteroids within 2 weeks prior to starting study drug or who have not recovered from side effects of such treatment, excluding conditions described in inclusion criteria for subjects with BMs.
  • Note: subjects with topical, intranasal, or inhaled corticosteroids administered; adrenal replacement steroid doses of ≤ 10 mg/day prednisone or the equivalent given; single-use glucocorticoids administered for prophylaxis of contrast media allergy prior to contrast-enhanced imaging are eligible for the study.
  • Subjects who are currently receiving treatment with medication that has a known risk to prolong the QT interval and cannot either be discontinued or switched to a different medication prior to starting study drug.
  • History of alcohol abuse or addiction within 3 months prior to the first dose.
  • Known, documented or suspected history of drug abuse, expect opioids prescribed for pain relief, etc.
  • Past or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might affect the results of the study, and interfere with the subject's participation and study compliance.
  • Other severe and/or uncontrolled concomitant diseases that could cause unacceptable safety risks or compromise compliance with the study protocol.
  • Other conditions that, in the judgement of the investigator, are inappropriate for enrollment in the study.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Tsinghua Changgeng Hospital

    Beijing, Beijing Municipality, 102218

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)

    Jinan, Shandong, 250117

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330200

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

  • Xuzhou Medical University Affiliated Hospital

    Xuzhou, Jiangsu, 221006

Other trials in China

About this study

Official title: 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 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).

Read the detailed description

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. The primary objective of this study is to evaluate the safety and tolerability of ABM-1310 monotherapy, and to determine MTD and RP2D. The study will be conducted in two stages:

Dose escalation stage: The dose escalation will be guided by a "3+3" design. In this study, the actual dose escalation will be based on a priming dose one level below the highest safe dose or two levels below the MTD that has been tested in US clinical trials when the enrolment of the China study actually initiates, and subsequent escalated doses may be adjusted as appropriate (e.g., the escalated doses following 150 mg BID in the China study may be adjusted to 200 mg BID, 250 mg BID and 300 mg BID. The actual priming dose and subsequent escalated doses for the China study are determined by the SMC).

Dose expansion stage: Subjects will begin to receive oral doses of ABM-1310, BID, for 28-day cycles at a fixed dose level (as determined at the dose escalation stage).The dose expansion stage is expected to include the following two cohorts of advanced solid tumors with BRAF V600 mutations:

Cohort 1: primary extracranial solid tumors, subjects with BMs preferentially enrolled, up to 15 patients per tumor type; Cohort 2: primary intracranial solid tumors, N = up to 30 patients.

Being tested
ABM-1310
Keywords
Melanoma, Non-small Cell Lung Cancer, Cholangiocarcinoma, intracranial solid tumor
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABM-1310Drug

    Dose escalation starting dose will be based on a priming dose one level below the highest safe dose or two levels below the MTD that has been tested in US clinical trials.

    Dose expansion will be initiated at the MTD or the optimal dose determined by the SMC as a fixed dose level.

Study groups in NCT05501912
Study groupRoleWhat they receive
Monotherapy Dose Escalation and Dose ExpansionExperimentalIn US studies, dose escalation started at a 25 mg BID dose and subsequent dose-escalation groups included: 50 mg BID, 100 mg BID, 150 mg BID, 225 mg BID and 325 mg BID. In this study, the actual dose escalation will be based on a priming dose one level below the highest safe dose or two levels below the MTD that has been tested in US clinical trials when the enrolment of the China study actually initiates, and subsequent escalated doses may be adjusted as appropriate (e.g., the escalated doses following 150 mg BID in the China study may be adjusted to 200 mg BID, 250 mg BID and 300 mg BID. The actual priming dose and subsequent escalated doses for the China study are determined by the SMC) The dose expansion stage in this study will be initiated at the MTD or the optimal dose determined by the 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).
Receives: Drug: ABM-1310

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    MTD is defined as the highest dose level at which DLT is observed in ≤ 1/6 subjects at one single dose group

    Measured: 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)

    RP2D will be a dose either below or equal to MTD

    Measured: 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)

    DLT will be evaluated according to NCI-CTCAE V5.0 criteria

    Measured: 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)

    Safety and tolerability of ABM-1310 monotherapy

    Measured: Up to 28 days from treatment discontinuation

  5. Number of participants with abnormal laboratory values

    Safety and tolerability of ABM-1310 monotherapy

    Measured: Up to 28 days from treatment discontinuation

  6. Number of participants with abnormal vital signs

    Safety and tolerability of ABM-1310 monotherapy

    Measured: Up to 28 days from treatment discontinuation

  7. Number of participants with abnormal physical examinations

    Safety and tolerability of ABM-1310 monotherapy

    Measured: Up to 28 days from treatment discontinuation

  8. Number of participants with abnormal ophthalmic evaluation

    Safety and tolerability of ABM-1310 monotherapy

    Measured: Up to 28 days from treatment discontinuation

  9. Number of participants with abnormal ECG

    Safety and tolerability of ABM-1310 monotherapy

    Measured: Up to 28 days from treatment discontinuation

  10. Number of participants with abnormal ECOG

    Safety and tolerability of ABM-1310 monotherapy

    Measured: Up to 28 days from treatment discontinuation

  11. Number of participants with abnormal Karnofsky PS

    Safety and tolerability of ABM-1310 monotherapy

    Measured: Up to 28 days from treatment discontinuation

Secondary outcomes (22)

  1. Area under the concentration time curve (AUC)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: only 5 days prior to dose escalation stage

  2. Maximum plasma concentration (Cmax)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: only 5 days prior to dose escalation stage

  3. Time to maximum plasma concentration (Tmax)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: only 5 days prior to dose escalation stage

  4. Half-life (T1/2)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: only 5 days prior to dose escalation stage

  5. Apparent plasma clearance (CL/F)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: only 5 days prior to dose escalation stage

  6. Apparent volume of distribution (Vz/F)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: only 5 days prior to dose escalation stage

  7. Area under the concentration time curve (AUC)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: Up to Day 1, Day 8, Day 15, Day 22 and Day 28 of Cycle 1. Up to Day 1 and Day 2 of Cycle2. After Cycle2, tests every 2 cycles (each cycle is 28 days)

  8. Maximum plasma concentration (Cmax)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: Up to Day 1, Day 8, Day 15, Day 22 and Day 28 of Cycle 1. Up to Day 1 and Day 2 of Cycle2. After Cycle2, tests every 2 cycles (each cycle is 28 days)

  9. Time to maximum plasma concentration (Tmax)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: Up to Day 1, Day 8, Day 15, Day 22 and Day 28 of Cycle 1. Up to Day 1 and Day 2 of Cycle2. After Cycle2, tests every 2 cycles (each cycle is 28 days)

  10. Half-life (T1/2)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: Up to Day 1, Day 8, Day 15, Day 22 and Day 28 of Cycle 1. Up to Day 1 and Day 2 of Cycle2. After Cycle2, tests every 2 cycles (each cycle is 28 days)

  11. Apparent plasma clearance (CL/F)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: Up to Day 1, Day 8, Day 15, Day 22 and Day 28 of Cycle 1. Up to Day 1 and Day 2 of Cycle2. After Cycle2, tests every 2 cycles (each cycle is 28 days)

  12. Apparent volume of distribution (Vz/F)

    Pharmacokinetic (PK) profile of ABM-1310 monotherapy

    Measured: Up to Day 1, Day 8, Day 15, Day 22 and Day 28 of Cycle 1. Up to Day 1 and Day 2 of Cycle2. After Cycle2, tests every 2 cycles (each cycle is 28 days)

  13. Objective Response Rate (ORR)

    Preliminary efficacy of ABM-1310 monotherapy

    Measured: From the enrollment of subjects to the time of disease progression in radiological imaging or death from any cause, whichever occurs first, assessed approximately 12 months.

  14. Disease Control Rate (DCR)

    Preliminary efficacy of ABM-1310 monotherapy

    Measured: From the enrollment of subjects to the time of disease progression in radiological imaging or death from any cause, whichever occurs first, assessed approximately 12 months.

  15. Duration of Response (DOR)

    Preliminary efficacy of ABM-1310 monotherapy

    Measured: From the enrollment of subjects to the time of disease progression in radiological imaging or death from any cause, whichever occurs first, assessed approximately 12 months.

  16. Progression free survival (PFS)

    Preliminary efficacy of ABM-1310 monotherapy

    Measured: From the enrollment of subjects to the time of disease progression in radiological imaging or death from any cause, whichever occurs first, assessed approximately 12 months.

  17. Intracranial Objective Response Rate (ORR)

    Preliminary intracranial efficacy of ABM-1310 monotherapy

    Measured: From the enrollment of subjects to the time of disease progression in radiological imaging or death from any cause, whichever occurs first, assessed approximately 12 months.

  18. Intracranial Disease Control Rate (DCR)

    Preliminary intracranial efficacy of ABM-1310 monotherapy

    Measured: From the enrollment of subjects to the time of disease progression in radiological imaging or death from any cause, whichever occurs first, assessed approximately 12 months.

  19. Intracranial Duration of Response (DOR)

    Preliminary intracranial efficacy of ABM-1310 monotherapy

    Measured: From the enrollment of subjects to the time of disease progression in radiological imaging or death from any cause, whichever occurs first, assessed approximately 12 months.

  20. Intracranial Progression free survival (PFS)

    Preliminary intracranial efficacy of ABM-1310 monotherapy

    Measured: From the enrollment of subjects to the time of disease progression in radiological imaging or death from any cause, whichever occurs first, assessed approximately 12 months.

  21. Deepness of Response（DPR）

    Preliminary efficacy of ABM-1310 monotherapy

    Measured: From the enrollment of subjects to the time of disease progression in radiological imaging or death from any cause, whichever occurs first, assessed approximately 12 months.

  22. Intracranial Deepness of Response（DPR）

    Preliminary intracranial efficacy of ABM-1310 monotherapy

    Measured: From the enrollment of subjects to the time of disease progression in radiological imaging or death from any cause, whichever occurs first, assessed approximately 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start1 Sep 2022
  3. Primary completion17 Jun 2024
  4. Study completion17 Jun 2024

Why it stopped: Adjustment of the applicant's research and development strategy

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study will be conducted in two stages: Dose escalation stage: To determine MTD/RP2D and evaluate the safety and tolerability of ABM-1310 monotherapy. Dose expansion stage: To further determine RP2D and evaluate the preliminary efficacy of ABM-1310 monotherapy.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501912
Sponsor's protocol ID
ABM1310X1101C
Status last verified
Nov 2024
First submitted
11 Aug 2022
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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    PubMed 27342992

  • Davies H, Bignell GR, Cox C, Stephens P, Edkins S, Clegg S, Teague J, Woffendin H, Garnett MJ, Bottomley W, Davis N, Dicks E, Ewing R, Floyd Y, Gray K, Hall S, Hawes R, Hughes J, Kosmidou V, Menzies A, Mould C, Parker A, Stevens C, Watt S, Hooper S, Wilson R, Jayatilake H, Gusterson BA, Cooper C, Shipley J, Hargrave D, Pritchard-Jones K, Maitland N, Chenevix-Trench G, Riggins GJ, Bigner DD, Palmieri G, Cossu A, Flanagan A, Nicholson A, Ho JW, Leung SY, Yuen ST, Weber BL, Seigler HF, Darrow TL, Paterson H, Marais R, Marshall CJ, Wooster R, Stratton MR, Futreal PA. Mutations of the BRAF gene in human cancer. Nature. 2002 Jun 27;417(6892):949-54. doi: 10.1038/nature00766. Epub 2002 Jun 9.

    PubMed 12068308

  • Wellbrock C, Karasarides M, Marais R. The RAF proteins take centre stage. Nat Rev Mol Cell Biol. 2004 Nov;5(11):875-85. doi: 10.1038/nrm1498.

    PubMed 15520807

  • Lovly CM, Dahlman KB, Fohn LE, Su Z, Dias-Santagata D, Hicks DJ, Hucks D, Berry E, Terry C, Duke M, Su Y, Sobolik-Delmaire T, Richmond A, Kelley MC, Vnencak-Jones CL, Iafrate AJ, Sosman J, Pao W. Routine multiplex mutational profiling of melanomas enables enrollment in genotype-driven therapeutic trials. PLoS One. 2012;7(4):e35309. doi: 10.1371/journal.pone.0035309. Epub 2012 Apr 20.

    PubMed 22536370

  • Fujio S, Juratli TA, Arita K, Hirano H, Nagano Y, Takajo T, Yoshimoto K, Bihun IV, Kaplan AB, Nayyar N, Fink AL, Bertalan MS, Tummala SS, Curry WT Jr, Jones PS, Martinez-Lage M, Cahill DP, Barker FG, Brastianos PK. A Clinical Rule for Preoperative Prediction of BRAF Mutation Status in Craniopharyngiomas. Neurosurgery. 2019 Aug 1;85(2):204-210. doi: 10.1093/neuros/nyy569.

    PubMed 30481321

  • Giunta EF, De Falco V, Napolitano S, Argenziano G, Brancaccio G, Moscarella E, Ciardiello D, Ciardiello F, Troiani T. Optimal treatment strategy for metastatic melanoma patients harboring BRAF-V600 mutations. Ther Adv Med Oncol. 2020 Jun 19;12:1758835920925219. doi: 10.1177/1758835920925219. eCollection 2020.

    PubMed 32612709

  • Schreck KC, Grossman SA, Pratilas CA. BRAF Mutations and the Utility of RAF and MEK Inhibitors in Primary Brain Tumors. Cancers (Basel). 2019 Aug 28;11(9):1262. doi: 10.3390/cancers11091262.

    PubMed 31466300

  • Khalifa J, Amini A, Popat S, Gaspar LE, Faivre-Finn C; International Association for the Study of Lung Cancer Advanced Radiation Technology Committee. Brain Metastases from NSCLC: Radiation Therapy in the Era of Targeted Therapies. J Thorac Oncol. 2016 Oct;11(10):1627-43. doi: 10.1016/j.jtho.2016.06.002. Epub 2016 Jun 23.

    PubMed 27343440

  • Carr S, Smith C, Wernberg J. Epidemiology and Risk Factors of Melanoma. Surg Clin North Am. 2020 Feb;100(1):1-12. doi: 10.1016/j.suc.2019.09.005. Epub 2019 Nov 4.

    PubMed 31753105

  • Chi Z, Li S, Sheng X, Si L, Cui C, Han M, Guo J. Clinical presentation, histology, and prognoses of malignant melanoma in ethnic Chinese: a study of 522 consecutive cases. BMC Cancer. 2011 Feb 25;11:85. doi: 10.1186/1471-2407-11-85.

    PubMed 21349197

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • Dienstmann R, Tabernero J. BRAF as a target for cancer therapy. Anticancer Agents Med Chem. 2011 Mar;11(3):285-95. doi: 10.2174/187152011795347469.

    PubMed 21426297

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Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABM-1310 in people with Advanced Solid Tumor and BRAF V600 Mutation, run by ABM Therapeutics Shanghai Company Limited at 10 sites in China.

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 28 inclusion and 42 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: stopped early, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. 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 was stopped early (reason given: Adjustment of the applicant's research and development strategy). Results are not available in the source record.

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: 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.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05501912, which also lists 22 linked publications.

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 29 Nov 2024.

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