TJ101 for Cancer

Recruiting at 4 trial locations

Overseen By Martin S Olivo, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Phrontline Biopharma

Must not be taking: Topoisomerase inhibitors, Mitomycin, Nitrosoureas, others

Disqualifiers: Interstitial lung disease, Cardiovascular disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called TJ101 (experimental treatment) to assess its safety and effectiveness for patients with advanced solid tumors who have no other treatment options. Researchers will determine the optimal dose and look for signs of the drug's effectiveness against cancer. Participants will receive the drug through an IV and attend regular check-ups to monitor tumor response. Individuals with advanced or metastatic solid tumors who have not found success with other treatments might be suitable for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, you cannot have received certain cancer treatments or strong/moderate CYP3A4 inhibitors recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that TJ101 is likely to be safe for humans?

Research has shown that TJ101, a new cancer treatment, appears promising for treating various solid tumors. In early lab and animal studies, TJ101 effectively targeted cancer cells and caused fewer side effects compared to other treatments.

The current trial aims to ensure TJ101's safety. Participants receive the drug through an IV drip, and researchers seek to determine the highest dose patients can tolerate without major side effects. As this is an early-stage study, detailed safety information for humans is not yet available, but the trial will closely monitor for any negative effects. Early trials are designed to quickly identify and manage potential risks.

Overall, while TJ101 has shown positive results in early studies, its safety in humans remains under close examination. Participants will be monitored carefully to ensure their safety as researchers learn more about the drug's effects in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TJ101 because it represents a novel approach in cancer treatment by targeting specific pathways involved in tumor growth. Unlike traditional chemotherapy, which attacks all rapidly dividing cells and can lead to significant side effects, TJ101 is designed to selectively target cancer cells, potentially reducing harm to healthy cells. Additionally, its intravenous administration every three weeks offers a more convenient dosing schedule, which might improve patient compliance and quality of life compared to some existing treatments.

What evidence suggests that TJ101 might be an effective treatment for advanced solid tumors?

Research has shown that antibody-drug conjugates (ADCs), such as TJ101, hold promise for treating certain cancers. These ADCs deliver cancer-fighting drugs directly to tumor cells, potentially leading to better outcomes. Early findings suggest that ADCs improve treatment results for some solid tumors. Although specific data on TJ101 remains limited, it is designed to target and destroy cancer cells while sparing healthy tissue. This targeted approach leads scientists to believe TJ101 might be effective for patients with advanced solid tumors. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

Adults with advanced solid tumors like lung, esophageal, or prostate cancer who have tried all standard treatments can join this trial. They'll get TJ101 through IV and be checked regularly for how their tumors respond and to monitor drug levels in the body.

Inclusion Criteria

Life expectancy of ≥ 12 weeks

Have at least one measurable lesion by RECIST v1.1 for solid tumors

Serum pregnancy test negative for female of childbearing potential within 7 days prior to first dosing of study treatment

Exclusion Criteria

Known hypersensitivity to any component of TJ101 or severe hypersensitivity reactions to other monoclonal antibodies

Received an investigational drug within specified time frames prior to first dose of TJ101

Positive virology status of hepatitis beyond specified criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Dose Escalation (Phase Ia)

Participants receive intravenous infusions of TJ101 at escalating dose levels to determine the maximum tolerated dose and recommended dose for expansion.

21 days per cycle

1 visit every 3 weeks

Dose Expansion (Phase Ib)

Participants receive TJ101 at the selected expansion dose to further assess safety and preliminary anti-tumor activity.

21 days per cycle

1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 30-day safety follow-up and survival follow-up every 3 months.

30 days for safety follow-up, ongoing for survival follow-up

What Are the Treatments Tested in This Trial?

Interventions

• TJ101

Trial Overview The study is testing TJ101, an experimental drug designed to target cancer cells. It aims to find the highest dose patients can take without serious side effects (MTD) and decide on a recommended dose for further research (RDE).

How Is the Trial Designed?

Group I: TJ101 Experimental Treatment 1 Intervention

TJ101 will be infused intravenously once every 3 weeks. Participants will receive TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose.

Who Is Running the Clinical Trial?

Phrontline Biopharma

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07181473

NCT07181473 | A Study to Evaluate the Safety, ... The goal of this clinical trial is to evaluate whether TJ101, an investigational antibody-drug conjugate (ADC), can safely and effectively ...

2. withpower.com withpower.com/trial/phase-1-lung-neoplasms-7-2025-a3ce3

TJ101 for Cancer · Recruiting Participants for Phase ... Participants are monitored for safety and effectiveness after treatment, including a 30-day safety follow-up and survival follow-up every 3 months.

3. synapse.patsnap.com synapse.patsnap.com/drug/80d206d367bd40e9be49debdd3f0d67c

TJ-101 (Phrontline) - Drug Targets, Indications, Patents Clinical Results associated with TJ-101 (Phrontline). Login to view more data. 100 Translational Medicine associated with TJ-101 (Phrontline).

4. prnewswire.com prnewswire.com/news-releases/phrontline-biopharma-announces-first-patient-dosed-in-phase-1-clinical-trial-of-tj101-302555704.html

Phrontline Biopharma Announces First Patient Dosed in ... The Phase 1 study of TJ101 will evaluate its safety, tolerability, pharmacokinetics, and preliminary antitumor activity across multiple solid ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12581584/

Antibody–drug conjugates in cancer therapy - PubMed Central This innovation significantly improved clinical outcomes in subsets of hematologic malignancies and solid tumors, marking a paradigm shift in ...

6. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/2955/755735/Abstract-2955-Preclinical-development-of-TJ101-a

Preclinical development of TJ101, a potent bispecific ADC ... TJ101 is a promising bispecific ADC with highly potent anti-tumor efficacy across multiple solid cancer types and preferable toxicity profiles.

7. ddw-online.com ddw-online.com/first-patient-dosed-in-phase-i-trial-of-antibody-drug-conjugate-tj101-36540-202509/

First patient dosed in Phase I trial of antibody-drug ... The Phase I study of TJ101, targeting EGFR/B7-H3, will evaluate its safety, tolerability, pharmacokinetics, and preliminary antitumour activity ...