Metastatic CancerPhase 1CHANCESNCT05143970
A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors
A Phase 1 study testing IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB in people with Metastatic Cancer and Metastatic Breast Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
CHANCES-IPC 2021-008 is First In Human, Phase I, multicenter, European study evaluating an anti-CD73, IPH5301 in advanced and/or metastatic cancer. The trial will be conducted in two parts, Part I- Dose escalation: This part aims to identify the maximum tolerated dose (MTD) of IPH5301 agent in monotherapy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Metastatic Breast Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2022to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Prior treatment with other monoclonal antibodies or small mol-ecules targeting CD73 or the adenosine pathway.
- Patients with known spinal cord compression.
- Patients with grade 2 or higher peripheral neuropathy.
- Symptomatic, untreated, or actively progressing central nerv-ous system (CNS) metastases. Patients with suspected CNS involvement at screening should have an magnetic resonance imaging (MRI) (preferred) or computed tomography (CT) each preferably with IV contrast of the brain prior to study entry to rule them out. Asymptomatic patients with treated CNS lesions are eligible, provided that definied criteria are met
- Known allergic reactions attributed to compounds of similar product.
- Patients with dyspnea at rest and history of pneumonit-is/interstitial lung disease.
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- Patients with any serious underlying medical condition that would impair the subject from receiving or tolerating the planned treatment.
- Concurrent enrollment in another clinical trial, unless it is an non-interventional clinical study or the follow-up period of an interventional study.
- Any concurrent treatment with any anti-cancer agents or drugs that could have anti-tumor effects.
- Active auto-immune disease within the past 2 years.
- ≥ Grade 3 immune related AE or an immune-related neuro-logic or ocular AE of any grade while receiving prior immunotherapy.
- Subjects who have undergone major surgery <28 days prior to starting study drug.
- Treatment with any conventional or investigational anticancer therapy within 28 days prior to day 1 of study treatment.
- Receipt of live attenuated vaccine or SARS-CoV-2 vaccine within 30 days prior to the first dose of study drug
- Primary immunodeficiency and/or history of allogenic transplantation.
- Current uncontrolled infection.
- Hepatitis B, C or HIV-positive patients.
- Subjects with a history of other active invasive malignancies during the past three years with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer).
- Pregnant or breastfeeding women.
- Participants with abnormal coagulation profiles or any history of coagulopathy within the 6 months prior to the first dose of IMP, as well as history of deep vein thrombosis, pulmonary embolism, cerebrovascular accident or other arterial thrombus. Participants being treated with an anticoagulant (eg, warfarin or heparin) for a thrombotic event that occurred more than 6 months before en-rollment, or for an otherwise stable and allowed medical condition (eg, well-controlled atrial fibrillation), provided that dose and co-agulation parameters (as defined by local standard of care) are stable for at least 1 month prior to the first dose of IMP are allowed.
- Subjects with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
CHANCES-IPC 2021-008 is First In Human, Phase I, multicenter, European study evaluating an anti-CD73, IPH5301 in advanced and/or metastatic cancer.
The trial will be conducted in two parts, Part I- Dose escalation: This part aims to identify the maximum tolerated dose (MTD) of IPH5301 agent in monotherapy and recommended phase 2 dose (RP2D) for future trials, followed by a safety expansion study part cohort.
Part II- Expansion cohort: A total of 12 HER2-expressing breast cancer patients is planned to be enrolled into the next expansion cohort to select a recommended dose of IPH5301 to be administered in combination with chemotherapy and trastuzumab for evaluation in future trials with selected advanced solid tumors.
- Conditions
- Metastatic Cancer, Metastatic Breast Cancer, Metastatic Pancreatic Cancer, Metastatic Gastric Cancer, Metastatic Lung Cancer, Metastatic Ovary Cancer
- Being tested
- IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Lung Neoplasms, Ovarian Neoplasms, Esophageal Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMABDrug
Part I-Dose escalation Patients will receive IPH5301 alone on day 1 (Week 1). Treatment will be administered every 2 weeks until progression or unacceptable toxicity or other reasons requiring treatment discon-tinuation, for a maximum duration of 12 months.
Part II- Expansion cohort Patients will receive IPH5301 at a recommended dose (RP2D) or a next lower dose (RP2D-1)in combination with trastuzumab and paclitaxel, at day 1 and every 2 weeks up to 6 cycles of paclitaxel. The RP2D dose will not exceed the designated maximum tolerated dose (MTD).
| Study group | Role | What they receive |
|---|---|---|
| IPH5301 administration | Experimental | Part I- Dose escalation:
Escalating dose levels of IPH5301 will be evaluated.
Part II-Cohort Expansion:
IPH5301 will be administrated in combination with trastuzumab and paclitaxel Receives: Drug: IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicity (DLT) of IPH5301 in monotherapy in the dose escalation and in combination with paclitaxel and trastuzumab in the expansion cohort
DLTs would include any grade 3 toxicity or higher that occurs during the first 4 weeks from the first injection of IPH5301, with the some exceptions
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start21 Jan 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- Innate Pharma
- Responsible party
- Sponsor
- Investigators
- Anthony GONCALVES, MD PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143970
- Sponsor's protocol ID
- CHANCES-IPC 2021-008
- Acronym
- CHANCES
- Status last verified
- Jun 2026
- First submitted
- 17 Nov 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05143970
- Acronym / sponsor ID
- CHANCES / CHANCES-IPC 2021-008
- Conditions
- Metastatic Cancer, Metastatic Breast Cancer, Metastatic Pancreatic Cancer, Metastatic Gastric Cancer, Metastatic Lung Cancer, Metastatic Ovary Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- Innate Pharma
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CHANCES-IPC 2021-008 is First In Human, Phase I, multicenter, European study evaluating an anti-CD73, IPH5301 in advanced and/or metastatic cancer.
The trial will be conducted in two parts, Part I- Dose escalation: This part aims to identify the maximum tolerated dose (MTD) of IPH5301 agent in monotherapy and recommended phase 2 dose (RP2D) for future trials, followed by a safety expansion study part cohort.
Part II- Expansion cohort: A total of 12 HER2-expressing breast cancer patients is planned to be enrolled into the next expansion cohort to select a recommended dose of IPH5301 to be administered in combination with chemotherapy and trastuzumab for evaluation in future trials with selected advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPH5301 administration | Experimental | Drug: IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMABPart I- Dose escalation: Escalating dose levels of IPH5301 will be evaluated. Part II-Cohort Expansion: IPH5301 will be administrated in combination with trastuzumab and paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- Prior treatment with other monoclonal antibodies or small mol-ecules targeting CD73 or the adenosine pathway.
- Patients with known spinal cord compression.
- Patients with grade 2 or higher peripheral neuropathy.
- Symptomatic, untreated, or actively progressing central nerv-ous system (CNS) metastases. Patients with suspected CNS involvement at screening should have an magnetic resonance imaging (MRI) (preferred) or computed tomography (CT) each preferably with IV contrast of the brain prior to study entry to rule them out. Asymptomatic patients with treated CNS lesions are eligible, provided that definied criteria are met
- Known allergic reactions attributed to compounds of similar product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMABPart I-Dose escalation Patients will receive IPH5301 alone on day 1 (Week 1). Treatment will be administered every 2 weeks until progression or unacceptable toxicity or other reasons requiring treatment discon-tinuation, for a maximum duration of 12 months. Part II- Expansion cohort Patients will receive IPH5301 at a recommended dose (RP2D) or a next lower dose (RP2D-1)in combination with trastuzumab and paclitaxel, at day 1 and every 2 weeks up to 6 cycles of paclitaxel. The RP2D dose will not exceed the designated maximum tolerated dose (MTD). | Drug | IPH5301 administration |
Primary outcome
Occurrence of dose limiting toxicity (DLT) of IPH5301 in monotherapy in the dose escalation and in combination with paclitaxel and trastuzumab in the expansion cohort
Time frame: 1 month
DLTs would include any grade 3 toxicity or higher that occurs during the first 4 weeks from the first injection of IPH5301, with the some exceptions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony GONCALVES, MD PhD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPH5301 ALONE OR IN COMBINATION WITH CHEMOTHERAPY AND TRASTUZUMAB in people with Metastatic Cancer and Metastatic Breast Cancer, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of dose limiting toxicity (DLT) of IPH5301 in monotherapy in the dose escalation and in combination with paclitaxel and trastuzumab in the expansion cohort (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.