A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhrontline Biopharma
About this trial
The goal of this clinical trial is to evaluate whether TJ101, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced solid tumors.
The main objectives of this study are :
* To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ101 * to show preliminary antitumor activity in patients with advanced solid tumors
Participants will:
* Receive intravenous (IV) infusions of TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose. * Undergo regular tumor imaging to assess response. * Provide blood samples for pharmacokinetics (PK) and biomarker analysis. * Be monitored for side effects and overall tolerability.
This study is being conducted in adult patients with advanced or metastatic solid tumors who have exhausted standard treatment options
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological and/or cytological diagnosis of advanced/metastatic solid tumors, who have failed standard treatment, or have no standard therapy.
Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors.
Men or women ≥18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1.
Disqualifiers
Has received treatment of topoisomerase 1 inhibitors (TOP1i), including topotecan, irinotecan, belotecan, and TOP1i-based antibody-drug conjugates (ADCs, eg, sacituzumab govitecan, trastuzumab deruxtecan, zalontamab brengitecan, sacituzumab tirumotecan etal);
Has known hypersensitivity to any component of TJ101 or has a history of severe hypersensitivity reactions to other monoclonal antibodies;
Has received mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil-like drugs such as S-1, capecitabine, or palliative radiotherapy within 2 weeks prior to the first administration; Has received other chemotherapy, biological therapy, immunotherapy, major surgery, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase) and other anti-tumor therapy within 5 half-lives or 28 days, whichever is shorter, prior to the first administration of TJ101; Has received anti-tumor herbal medicine within 14 days prior to first dose of TJ101;
Has received a strong or moderate CYP3A4 inhibitor within 3 half-lives;
Trial design
Design model
Single group
Treatments tested in this trial
TJ101
DrugTJ101 is a EGFR/B7H3 directed antibody conjugate with a cleavable linker and a noval topoisomerase I inhibitor.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: TJ101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with Dose-limiting toxicities
Measuring the number of patients with Dose-limiting toxicities (DLTs). A DLT is defined as any of the following events that are not clearly due to the underlying disease or extraneous causes: Hematological toxicities: Grade 4 neutrophil count decreased lasting \>7 days; Grade ≥3 febrile neutropenia; Grade ≥3 platelet count decreased with clinically significant hemorrhage; Grade 4 anaemia; Non-Hematological toxicities: Death; Hy's law cases; Grade ≥3 non-hematological toxicities.
Time frame
21 Days2
Number of participants with Serious Adverse Events (SAEs)
Measuring the number of patients with Serious Adverse Events (SAEs)
Time frame
2 years3
Number of participants with treatment-emergent adverse events (TEAEs)
Measuring the number of patients with AEs that occur after first study dose till 30 days after the last dose
Time frame
2 years4
Number of participants with treatment-related adverse events (TRAEs)
Measuring the number of patients with treatment-related TEAEs
Time frame
2 yearsSecondary outcomes
1
Objective response rate (ORR)
Measuring the proportion of patients with complete or partial response according to RECIST 1.1 during the study
Time frame
2 years2
Disease control rate (DCR)
Measuring the proportion of patients with complete response, partial response or stable disease according to RECIST 1.1 during the study
Time frame
2 years3
Duration of response (DoR)
Measuring the time from the first assessment of CR or PR until the date of the first occurrence of PD or death, whichever occurs first.
Time frame
2 years4
Progression-free survival (PFS)
Measuring the time from initiation of study treatment to the occurrence of PD or death, whichever occurs first.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov