New pill targets rare cancer drivers in chinese patients
NCT ID NCT04280081
First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 2 times
Summary
This phase 2 study tests an oral drug called selpercatinib in 77 people in China who have advanced solid tumors or medullary thyroid cancer with specific RET gene changes. The goal is to see if the drug can shrink tumors and how safe it is. Participants take the pill daily, and doctors monitor their response using standard cancer measurement criteria.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Selpercatinib (a targeted oral drug that blocks RET proteins driving cancer growth)
- What this could lead to
- If successful, this could provide a new treatment option for people in China with certain RET-altered cancers, potentially shrinking tumors and delaying progression.
- What could go wrong
- This is a mid-stage trial with only 77 participants, so results may not apply broadly. Selpercatinib can cause side effects like liver issues, high blood pressure, and fatigue, and not all patients may respond.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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77 people
The number who actually took part.
- Started
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Mar 2020
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Participants with a locally advanced or metastatic solid tumor. * Evidence of a RET gene alteration in tumor and/or blood. * Measurable or non-measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2, with no sudden deterioration 2 weeks prior to the first dose of study treatment. * Archived tumor tissue sample available for cohort 1 and 2. * Cohorts 1 and 2: failed or intolerant to standard of care. * Cohorts 1-2: enrollment will be restricted to participants with evidence of a RET gene alteration in tumor (i.e., not just blood). However, a positive germline DNA test for a RET gene mutation as defined in the protocol is acceptable in the absence of tumor tissue testing for participants with MTC. * Cohorts 1-2: at least one measurable lesion as defined by RECIST v1.1 and not previously irradiated (unless progressive disease for the irradiated lesion\[s\] has been radiographically documented). Exclusion Criteria: * Cohorts 1-2, an additional validated oncogenic driver that could cause resistance to selpercatinib treatment if known. * Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor(s), such as BLU-667, RXDX-105, etc). * Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. * Any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events (CTCAE) Grade 1 except where otherwise noted in this eligibility criteria at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum therapy-related neuropathy. * Symptomatic primary central nervous system (CNS) tumor, symptomatic CNS metastasis, leptomeningeal carcinomatosis, or untreated spinal cord compression. * Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds. * History of Human Immunodeficiency Virus (known HIV 1/2 antibodies positive); participants with unknown HIV status do not need to be tested. * History of active hepatitis B (known positive hepatitis B surface antigen \[HbsAg\] and quantitative hepatitis B DNA greater than the upper limit of detection of the assay) or C (known positive hepatitis C antibody and quantitative hepatitis C RNA greater than the upper limit of detection of the assay); participants with unknown hepatitis B/hepatitis C status do not need to be tested. * Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required. * Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug. * Uncontrolled symptomatic hyperthyroidism or hypothyroidism * Uncontrolled symptomatic hypercalcemia or hypocalcemia. * Concurrent use of drugs known to prolong QTc. * Pregnancy or lactation. Breast-feeding should be interrupted when selpercatinib is started; breast-feeding can be resumed 3 months after discontinuation of selpercatinib. * Active second malignancy other than minor treatment of indolent cancers with prior sponsor approval.
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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
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Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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Hunan Cancer Hospital
Changsha, Hunan, 410013, China
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Jilin Cancer Hospital
Changchun, Jilin, 130000, China
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Jinan Central Hospital
Jinan, Shandong, 250013, China
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Shanghai Chest Hospital
Shanghai, Shanghai/China, 200030, China
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Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
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Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515, China
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The First Affiated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
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The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003, China
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Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
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Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
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