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Experimental antibody HH-101 tested in 12 patients with advanced cancers

NCT ID NCT07554196

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested an experimental drug called HH-101 in 12 people with advanced solid tumors that had not responded to standard treatments. The main goal was to check the drug's safety and find the right dose. Participants received HH-101 as an IV infusion every three weeks. The study is now complete, but results on effectiveness are not yet available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HH-101 (an experimental antibody drug given by IV infusion)
What this could lead to
If safe and effective, HH-101 could become a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 12 participants, so it is too small to prove effectiveness. The drug may cause side effects or fail to shrink tumors in larger studies.

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

12 people

The number who actually took part.

Started

Jan 2022

Finished

Mar 2024

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

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntary signing of the written informed consent form; * Histologic or cytologic confirmation of advanced solid tumor; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; * Have an estimated life expectancy ≥3 Months, in the judgement of the investigator; * Must have at least 1 measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Exclusion Criteria: * History of other malignancies within 5 years prior to the first dose of study drug, except for malignancies that have been cured after treatment, such as thyroid cancer, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the breast. * Receipt of the last systemic anti-tumor therapy within 2 weeks prior to the first dose of study drug, including chemotherapy, radiotherapy, targeted therapy, or traditional Chinese herbal medicine or patent Chinese medicines with anti-tumor activity. Patients who received tumor immune checkpoint inhibitor therapy within 4 weeks prior to the first dose of study drug. * Adverse reactions from previous treatments that have not recovered to CTCAE v5.0 Grade 1 or lower (except for alopecia and neuropathy, which, in the Investigator's judgment, are long-standing and not expected to recover). * Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation. * If female, is pregnant, breastfeeding, or planning to become pregnant. * Known hypersensitivity to HH-101 Injection or any of its components. History of severe hypersensitivity reactions to other therapeutic antibody drugs. Known allergy to multiple substances or history of severe allergic diseases. * Known interstitial lung disease or non-infectious pneumonitis requiring steroid therapy. * Other severe, acute, or chronic medical conditions, psychiatric disorders, or laboratory abnormalities that, in the Investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results.

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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

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.