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New immunotherapy combo shows promise for Hard-to-Treat cancers

NCT ID NCT05024214

Disease control Sponsor: 3D Medicines (Sichuan) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether combining two drugs—Envafolimab (an immunotherapy injection) and Lenvatinib (a daily pill)—can shrink tumors in people with advanced solid cancers like lung, kidney, and liver cancer. About 170 adults whose cancer has worsened after standard treatment will receive the combo. The goal is to see if more tumors respond compared to usual care.

What this could mean

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

Active substance
Envafolimab (an immunotherapy drug) and Lenvatinib (a targeted cancer drug)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is an early-phase trial (Phase 1b/2) with a small number of participants, so results may not apply broadly. The drugs can cause side effects like fatigue, high blood pressure, and immune-related reactions.
Why investors are watching

3D Medicines is running a Phase Ib/II trial testing its drug envafolimab combined with lenvatinib in 170 patients with advanced solid tumors. The trial measures whether the combination improves the objective response rate, meaning the share of patients whose tumors shrink, compared to standard care. For a small company, this readout matters because envafolimab is a core asset, and a positive result could support broader use and regulatory discussions.

If it works: A positive result could show that the combination works better than standard care, which may strengthen the company's position in the immunotherapy market and support further development of envafolimab. It could also attract partnership interest from larger drugmakers.

If it fails: The trial could fail to show a better response rate, or the combination could prove too toxic for patients. Trials in advanced solid tumors often miss their goals, and a negative result would likely set back the drug's development and hurt the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

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 years and older

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: 1. Eighteen years and older; 2. phase Ib:Histological or cytological diagnosis of Locally advanced or metastatic solid tumors (excluding hepatocellular carcinoma and thyroid carcinoma) that have progressed after standard treatment or are intolerant or have no effective treatment; 3. phase II cohort 1:Histological or cytological diagnosis of NSCLC，RCC, HCC, resistance to previous treatment with PD-(L)1 inhibitor; previous system treatment lines≤2; 4. phase II cohort 2：Unresectable locally advanced or metastatic or recurrent RCC; 5. Tumor tissue samples or biopsies from FFPE archived or fresh biopsies with locally advanced/metastatic disease must be provided, and if biopsies are not available, samples obtained prior to receiving adjuvant/neoadjuvant chemotherapy are allowed; 6. phase Ib and phase II cohort 1: Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1; Phase II cohort 2: Karnofsky physical status (KPS) assessment ≥70； 7. Life expectancy of at least 12 weeks; 8. At least one measurable lesion per RECIST 1.1; 9. Adequate organ function; 10. Signed informed consent. Exclusion Criteria: 1. Prior anticancer treatment within 4 weeks prior to the first dose of study drugs; 2. Toxicity from prior anticancer therapy prior to the first dose of study drugs not recovered to ≤ grade1; 3. Hypertension did not satisfactory controlled after antihypertensive medication 4. Phase Ib/II: Subjects who were previously treated with Lenvatinib or who participated in a clinical trial of a generic version of Lenvatinib 5. Phase II cohort 1, intolerance to treatment with A PD-(L)1 inhibitor; History of severe digestive disease that can affect the oral absorption of Lenvatinib/Sunitinib; 6. Uncontrollable or significant cardiovascular or cerebrovascular disease; 7. Active, known history or suspected autoimmune disease; 8. Have used or require treatment with \>10 mg/day of prednisone or an equivalent dose of systemic corticosteroids within 14 days prior to the first dose of study drugs; 9. have received live attenuated vaccine within 28 days prior to the first study drug treatment or are scheduled to receive it during the study period; 10. Subjects with known or suspected interstitial pneumonia; 11. Any serious active infection requiring systemic antibacterial, antifungal or antiviral therapy at screening, including active tuberculosis; Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) 12. Active hepatitis B or hepatitis C; 13. Known history of severe gastrointestinal bleeding or active hemoptysis or other severe bleeding within 6 months prior to first study drug therapy; 14. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ; 15. Known active or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis; 16. Have other primary malignancies within 5 years; 17. Known history of contraindications or hypersensitivity reactions to any investigational drug component or any known excipients 18. Women who are pregnant or breastfeeding. 19. Radiographic evidence of major blood vessel invasion/infiltration may be considered for enrollment if the investigator assesses that the risk is manageable.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma neoplasm non-small cell lung carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma Non-small cell lung cancer Renal cell carcinoma Solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Dongguan People's Hospital

    RECRUITING

    Dongguan, Guangdong, 523059, China

  • First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, Shanxi, 030001, China

  • Fudan University

    RECRUITING

    Shanghai, China

  • Fujian Medical University Union Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350001, China

  • Harbin Medical University Cancer Hospital

    NOT_YET_RECRUITING

    Haerbin, Heilongjiang, 150081, China

  • Jilin Cancer Hospital

    NOT_YET_RECRUITING

    Changchun, Jilin, 130028, China

  • Liaoning Cancer Hospital & Institute

    RECRUITING

    Shenyang, Liaoning, 110011, China

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310020, China

  • THE First Hospital of Jilin University

    NOT_YET_RECRUITING

    Changchun, Jilin, 130012, China

  • The 960th Hospital of the PLA Joint Logistics Support Force

    RECRUITING

    Jinan, Shandong, 250031, China

  • The Cancer Affiliated Hospital of Xinjiang Medical College

    RECRUITING

    Ürümqi, Xinjiang, 830011, China

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    RECRUITING

    Zhuhai, Guangdong, 519000, China

  • The First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, 116011, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The Second Affiliater Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The Seventh Medical Center of the PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100700, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, 650118, China

  • Zhongshan Hospital,Fudan University(Xiamen Branch)

    NOT_YET_RECRUITING

    Xiamen, Fujian, 361015, China

  • Zhujiang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510280, China

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