169 Participants Needed

ABSK121-NX for Solid Tumors

Recruiting at 23 trial locations
ML
YL
Overseen ByYuan Lu
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called ABSK121-NX for patients with advanced solid tumors. It aims to find the safest dose and see if the drug can help reduce or control the tumors.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take potent inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of the study treatment (3 weeks for St John's Wort). Also, previous anti-cancer therapies must be stopped at least 2 to 6 weeks before starting the study treatment, depending on the type of therapy.

What safety data exists for ABSK121-NX treatment?

The provided research does not contain specific safety data for ABSK121-NX, ABSK-121, or ABSK121-NX. The studies focus on ALK inhibitors and other tyrosine kinase inhibitors, but none mention ABSK121-NX or its variants. Therefore, no direct safety data for ABSK121-NX is available from these sources.12345

Is the drug ABSK121-NX a promising treatment for solid tumors?

The information provided does not directly mention ABSK121-NX or its effects on solid tumors. Therefore, we cannot determine if ABSK121-NX is a promising treatment based on the given research articles.678910

What data supports the idea that ABSK121-NX for Solid Tumors is an effective treatment?

The available research does not provide specific data on the effectiveness of ABSK121-NX for Solid Tumors. Instead, it discusses other treatments and targets, such as AXL-targeted therapies, which have shown promise in treating various cancers by improving survival rates and reducing tumor growth. Without direct data on ABSK121-NX, we cannot conclude its effectiveness compared to these alternatives.1112131415

Who Is on the Research Team?

YL

Yuan Lu

Principal Investigator

Wuxi Abbisko Biomedical Technology Co., Ltd.

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have specific genetic changes in FGFR genes. Participants must be over 18, have a life expectancy of at least 3 months, measurable cancer according to certain criteria, and good organ and bone marrow function. They can't join if they've had recent cancer treatments or surgeries, are unable to swallow pills, or have other active cancers.

Inclusion Criteria

Patients should understand, sign, and date the written informed consent form prior to screening
Life expectancy ≥3 months
For the expansion Part:
See 7 more

Exclusion Criteria

I am scheduled for a major surgery during the study.
My phosphate levels have been high despite treatment.
Expansion part:
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation of oral ABSK121-NX guided by the Bayesian optimal interval (BOIN) design to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).

28-day cycles
Multiple visits for dose escalation and monitoring

RDE Confirmation

RDE-confirmation group of up to 24 patients to further evaluate safety and efficacy at the recommended dose for expansion.

28-day cycles
Regular visits for safety and efficacy evaluation

Dose Expansion

Expansion phase to evaluate safety and tolerability among selected tumor types at the recommended dose for expansion.

28-day cycles
Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • ABSK121-NX
Trial Overview ABSK121-NX is being tested in this study. It starts with dose escalation to find the safest dose that patients tolerate well and then expands to more patients at this dose. The drug is taken orally in repeated cycles every 28 days to check its safety and how it affects different types of tumors.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ABSK121-NXExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abbisko Therapeutics Co, Ltd

Lead Sponsor

Trials
26
Recruited
1,700+

Published Research Related to This Trial

The antibody-drug conjugate AXL-107-MMAE effectively targets AXL-high cancer cells, showing strong anti-tumor activity in various cancers, including melanoma and lung cancer, in patient-derived xenograft models.
Combining AXL-107-MMAE with MAPK pathway inhibitors enhances tumor growth inhibition by targeting different cell populations within heterogeneous tumors, suggesting a promising strategy for treating both treatment-naive and drug-resistant cancers.
Cooperative targeting of melanoma heterogeneity with an AXL antibody-drug conjugate and BRAF/MEK inhibitors.Boshuizen, J., Koopman, LA., Krijgsman, O., et al.[2022]
In a study of 332 ductal breast cancer patients, the phosphorylation of the androgen receptor at ser515 (AR-515) combined with pERK1/2 was linked to improved cancer-specific survival and better tumor characteristics in estrogen receptor-positive (ER+) tumors.
Conversely, in triple negative breast cancer (TNBC) patients, AR-515 phosphorylation was associated with poorer cancer-specific survival, suggesting it may play a role in inflammation regulation and could serve as a prognostic marker and therapeutic target for TNBC.
Phosphorylation of androgen receptors at serine 515 is a potential prognostic marker for triple negative breast cancer.Roseweir, AK., McCall, P., Scott, A., et al.[2018]
AXL, a receptor tyrosine kinase, is expressed in Ewing sarcoma (ES) tumors, with high levels correlating to poorer overall survival, indicating its potential as a prognostic marker.
The AXL-inhibitor BGB324 effectively reduced cell viability and migration in Ewing sarcoma cell lines and enhanced the effectiveness of chemotherapy drugs, suggesting AXL as a promising therapeutic target for treatment.
The role of AXL and the in vitro activity of the receptor tyrosine kinase inhibitor BGB324 in Ewing sarcoma.Fleuren, ED., Hillebrandt-Roeffen, MH., Flucke, UE., et al.[2022]

Citations

Cooperative targeting of melanoma heterogeneity with an AXL antibody-drug conjugate and BRAF/MEK inhibitors. [2022]
Phosphorylation of androgen receptors at serine 515 is a potential prognostic marker for triple negative breast cancer. [2018]
The role of AXL and the in vitro activity of the receptor tyrosine kinase inhibitor BGB324 in Ewing sarcoma. [2022]
Differential expression of Axl and correlation with invasion and multidrug resistance in cancer cells. [2022]
Preclinical Development of ADCT-601, a Novel Pyrrolobenzodiazepine Dimer-based Antibody-drug Conjugate Targeting AXL-expressing Cancers. [2023]
The safety and serious adverse events of approved ALK inhibitors in malignancies: a meta-analysis. [2020]
First-in-Class ERK1/2 Inhibitor Ulixertinib (BVD-523) in Patients with MAPK Mutant Advanced Solid Tumors: Results of a Phase I Dose-Escalation and Expansion Study. [2021]
Risks of cardiovascular toxicities associated with ALK tyrosine kinase inhibitors in patients with non-small-cell lung cancer: a meta-analysis of randomized control trials. [2023]
Treatment-related mortality with vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy in patients with advanced solid tumors: a meta-analysis. [2022]
Cardiovascular toxicities following the use of tyrosine kinase inhibitors in hepatocellular cancer patients: a retrospective, pharmacovigilance study. [2023]
XK469, a novel antitumor agent, inhibits signaling by the MEK/MAPK signaling pathway. [2021]
Investigation of neurotrophic tyrosine kinase receptor 1 fusions and neurotrophic tyrosine kinase receptor family expression in non-small-cell lung cancer and sensitivity to AZD7451 in vitro. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Mechanisms of Resistance to NTRK Inhibitors and Therapeutic Strategies in NTRK1-Rearranged Cancers. [2020]
Establishment and characterization of NCC-MFS6-C1: a novel patient-derived cell line of myxofibrosarcoma. [2022]
15.United Statespubmed.ncbi.nlm.nih.gov
New targets bring hope in squamous cell lung cancer: neurotrophic tyrosine kinase gene fusions. [2023]
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