New antibody drug tested in patients with Hard-to-Treat cancers
NCT ID NCT05105971
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested a new drug called BAT6026 in 30 adults with advanced solid tumors that had stopped responding to standard treatments. The main goal was to check the drug's safety and find the best dose. Researchers also looked at how the drug moves through the body and whether it shows any signs of shrinking tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BAT6026 (anti-OX40 monoclonal antibody)
- What this could lead to
- If this trial succeeds, it could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early Phase 1 study with only 30 participants, focused on safety and dosing. The drug may not show anti-tumor activity or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
30 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
-
Nov 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age: ≥18 years of age ≤75 years of age, gender: men and women are not limited; 2. The investigator estimates that the expected survival period is at least 3 months; 3. The Eastern Cooperative Oncology Group (ECOG) performance status scoring requirement is 0 or 1; 4. Patients with locally advanced or metastatic solid tumors diagnosed by pathology who have failed standard treatment or have no effective treatment methods (refer to CSCO guidelines in 2021); 5. According to the tumor efficacy evaluation standard RECIST 1.1, there must be at least one measurable tumor lesion during the dose expansion stage; Exclusion Criteria: 1. Have received anti-OX40 monoclonal antibody or double-antibody drug therapy with anti-OX40 activity in the past; 2. It is receiving or expected to receive other anti-tumor treatments during the first study drug administration, including but not limited to chemotherapy, radiotherapy, immunotherapy, hormone therapy (except alternative therapies), targeted therapy, biological therapy, and anti-tumor effects Chinese patent medicine, etc.; 3. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time, except for the following items:? Nitrosourea or Mitomycin C is within 6 weeks before the first use of the study drug;? Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first use of the study drug or 5 half-lives of the drug (whichever is longer);? Chinese medicine with anti-tumor indications should be within 2 weeks before the first use of the study drug; 4. Clinical investigators who are participating in this study or who have participated in experimental drugs or medical devices within 4 weeks before the first administration of this study cannot be included; 5. Have been vaccinated within 4 weeks before the first administration or plan to vaccinate live/attenuated vaccines and mRNA vaccines during the study period; 6. Pregnant or lactating women; 7. Patients whose AEs caused by the original anti-tumor therapy within 4 weeks before the first administration of the study drug did not return to CTCAE 5.0≤1 (except for hair loss and fatigue ≤2); previous irAE ≥3 or any level of irAE Those who have terminated immunotherapy; 8. Major surgery (defined as grade 3 and 4 surgery) within 4 weeks before the first administration; 9. Those who have a history of tissue or organ transplantation; 10. Subjects who have had serious infections within 4 weeks before the first administration, including but not limited to infectious complications that require hospitalization, bacteremia, severe pneumonia, etc.; subjects with active infections before the first administration are excluded By;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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