Clear Cell Renal Cell Carcinoma MetastaticPhase 1CAMP1NCT05698238
Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours
A Phase 1 study testing CA9hu-1 in people with Clear Cell Renal Cell Carcinoma Metastatic and TNBC - Triple-Negative Breast Cancer, run by Mabpro, a.s..
Trial summary
Carbonic anhydrase IX (CA IX) has been implicated in the progression of most solid tumours and expression has been demonstrated in clinical samples from a variety of solid cancers. High expression is often associated with high grade or metastatic disease and poor prognosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma Metastatic, TNBC - Triple-Negative Breast Cancer, Head and Neck Cancer
- What is being tested?
- CA9hu-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
- Histologically proven solid tumors (Clear Cell Renal Cell Carcinoma Metastatic, Triple-Negative Breast Cancer, Head and Neck Cancer, Non-small-cell Lung Carcinoma, Malignant Mesothelioma) refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient
- Life expectancy of at least 12 weeks
- World Health Organization (WHO) performance status of 0 or 1
- Hematological and biochemical indices within the ranges (hemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1.5 x 109/L, platelet count ≥100 x 109/L, bilirubin ≤1.5 x upper limit of normal, alanine amino-transferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x upper limit of normal. These measurements must be performed within one week (Day -7 to Day -1) before the patient receives their first infusion of CA9hi-1.
- Calculated creatinine clearance or isotope clearance measurement ≥ 50 mL/min
- PT/APTT ≤1.5 upper limit of normal
Who cannot join
- Ongoing toxic manifestations of previous treatments (Grade 2 or greater according to NCI-CTCAE v4.02) with the exception of alopecia or certain Grade 2 toxicities, which in the opinion of the investigator and CDD should not exclude the patient - these should be discussed on a case by case basis
- Symptomatic brain metastases or spinal cord compression
- Patients who have received prior radiotherapy to their lungs will not be eligible for this trial.
- Female patients who are able to become pregnant (or already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral; injected or implanted hormonal contraception and condom; have an intra-uterine device and condom; diaphragm with spermicidal gel and condom) effective at the first administration of CA9hu-1, throughout the trial and for six months afterwards are considered eligible. Breast feeding should be discontinued if the mother is treated with CA9hu-1.
- Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] effective at the first administration of hu-CA91, throughout the trial and for six months afterwards). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example: condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
- Any major surgical procedure within 4 weeks prior to patients scheduled Cycle 1 Day 1, any major thoracic or abdominal surgery from which the patient has not yet recovered.
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- A serious or non-healing active wound, ulcer, or bone fracture.
- At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV) or who have an active, ongoing infection or an active, known or suspected autoimmune disease or on systemic steroids.
- Concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]), prior history of cardiac ischemia or prior history of cardiac arrhythmia.
- Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I study of CA9hu-1. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator and Medical Advisor would be acceptable.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
About this study
Official title: Phase Ib/ll Clinical Study to Evaluate Safety and Dosing of Humanised Monoclonal Antibody CA9hu-1 to Human Carbonic Anhydrase IX in Patients With Advanced Solid Tumours
Carbonic anhydrase IX (CA IX) has been implicated in the progression of most solid tumours and expression has been demonstrated in clinical samples from a variety of solid cancers. High expression is often associated with high grade or metastatic disease and poor prognosis. CA IX is not expressed in normal tissue, potentially providing a cancer-associated target that would not likely result in significant interruption of normal biologic function in organs not affected by cancer. A humanized monoclonal antibody CA9hu-1 has shown robust activity in a variety of tumour models including models of ovarian, prostate, breast, pancreatic, colon and lung where tumour growth and metastasis are inhibited when CA9hu-1 is used as a monotherapy. Enhancement of chemotherapy has also been demonstrated in several models in combination with CA9hu-1. CA IX is also expressed by tumour-associated cells (angiogenic endothelium, tumour-associated macrophages), which also drive cancer progression. Thus, targeting CA IX with CA9hu-1 in cancer patients is expected to affect multiple pathways and multiple tumour compartments that are important to tumour progression. Taken together, there is strong rationale for developing hu-CA91 for the treatment of advanced cancer. The present study was designed to establish safety and toxicity profile and maximum tolerated dose of CA9hu-1, evaluate pharmacokinetics, investigate the presence of anti-drug antibody, to document anti-tumour activity at a clinically relevant dose, and to document the use of [18F]FLT-PET as a biomarker for detection of early tumour response at a clinically relevant dose.
- Conditions
- Clear Cell Renal Cell Carcinoma Metastatic, TNBC - Triple-Negative Breast Cancer, Head and Neck Cancer, Non-small-cell Lung Carcinoma, Mesothelioma, Malignant
- Being tested
- CA9hu-1
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma, Triple Negative Breast Neoplasms, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA9hu-1Drug
Humanized monoclonal antibody to human carbonic anhydrase IX
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Drug: CA9hu-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events to CA9hi-1 and grading their severity according to the National Cancer Institute's Common Terminology Criteria for adverse Events (NCI CTCAE) Version 4.02.
The primary objective of this outcome is to establish the safety and toxicity profile of hu-CA91.
Measured: 6 months
Number of patients reaching the dose levels of 750 mg of CA9hu-1 without any dose limiting toxicities.
The objective of this outcome is to perform a dose escalation of of CA9hu-1 to levels of 750mg without any dose limiting toxicities.
Measured: 4 weeks
Number of patients reaching pharmacologically active dose measurement of CA9hu-1
The objective of this outcome is to determine number of patients in whom the pharmacologically active dose of CA9hu-1 wil be reached by measurement of plasma concentrations of the CA9hu-1. In order to reach the proposed pharmacologically active dose, the plasma levels of 200 +/- 100 nM are necessary.
Measured: 4 weeks
Maximum tolerated dose of CA91hu-1
The objective is to determine a dose at which no more than one patient out of up to six patients at the same dose level experience a highly probable or probable CA9hu-1 related dose limiting toxicity.
Measured: 4 weeks
Secondary outcomes (6)
Half-life of CA9-hu-1
Measurement of CA9hu-1 half-life after human administration provides basic PK descriptive data.
Measured: 4 weeks
Peak Plasma Concentration (Cmax) of CA9hu-1
The measurement of Cmax after CA9hu-1 administration will provide basic PK descriptive parameter of the drug.
Measured: 4 weeks
Area under the plasma concentration versus time curve (AUC)
The measurement of AUC after CA9hu-1 administration will provide basic PK parameter of the drug.
Measured: 4 weeks
Anti-drug antibodies
Analyses of plasma samples for presence of anti-drug antibodies following CA9hu-1 administration
Measured: 6 months
Anti-tumour activity of CA9hu-1
Evaluate response (stable disease, partial response or complete response) in any of the patients as determined by the Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST).
Measured: 6 months
Biomarker for detection of early tumour response
Determination of the magnitude of change in apparent standard uptake volume (SUV) calculated from the uptake of FLT by tumour tissue quantified by [18F]FLT-PET during the second cycle of CA9hu-1 treatment and the relation with response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell Carcinoma MetastaticStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabpro, a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698238
- Sponsor's protocol ID
- MP01
- Acronym
- CAMP1
- Status last verified
- Mar 2023
- First submitted
- 4 Jan 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/ll Clinical Study to Evaluate Safety and Dosing of Humanised Monoclonal Antibody CA9hu-1 to Human Carbonic Anhydrase IX in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT05698238
- Acronym / sponsor ID
- CAMP1 / MP01
- Conditions
- Clear Cell Renal Cell Carcinoma Metastatic, TNBC - Triple-Negative Breast Cancer, Head and Neck Cancer, Non-small-cell Lung Carcinoma, Mesothelioma, Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mabpro, a.s.Industry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Jan 2023 (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.
Carbonic anhydrase IX (CA IX) has been implicated in the progression of most solid tumours and expression has been demonstrated in clinical samples from a variety of solid cancers. High expression is often associated with high grade or metastatic disease and poor prognosis. CA IX is not expressed in normal tissue, potentially providing a cancer-associated target that would not likely result in significant interruption of normal biologic function in organs not affected by cancer. A humanized monoclonal antibody CA9hu-1 has shown robust activity in a variety of tumour models including models of ovarian, prostate, breast, pancreatic, colon and lung where tumour growth and metastasis are inhibited when CA9hu-1 is used as a monotherapy. Enhancement of chemotherapy has also been demonstrated in several models in combination with CA9hu-1. CA IX is also expressed by tumour-associated cells (angiogenic endothelium, tumour-associated macrophages), which also drive cancer progression. Thus, targeting CA IX with CA9hu-1 in cancer patients is expected to affect multiple pathways and multiple tumour compartments that are important to tumour progression. Taken together, there is strong rationale for developing hu-CA91 for the treatment of advanced cancer. The present study was designed to establish safety and toxicity profile and maximum tolerated dose of CA9hu-1, evaluate pharmacokinetics, investigate the presence of anti-drug antibody, to document anti-tumour activity at a clinically relevant dose, and to document the use of [18F]FLT-PET as a biomarker for detection of early tumour response at a clinically relevant dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: CA9hu-1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
- Histologically proven solid tumors (Clear Cell Renal Cell Carcinoma Metastatic, Triple-Negative Breast Cancer, Head and Neck Cancer, Non-small-cell Lung Carcinoma, Malignant Mesothelioma) refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient
- Life expectancy of at least 12 weeks
- World Health Organization (WHO) performance status of 0 or 1
- Hematological and biochemical indices within the ranges (hemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1.5 x 109/L, platelet count ≥100 x 109/L, bilirubin ≤1.5 x upper limit of normal, alanine amino-transferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x upper limit of normal. These measurements must be performed within one week (Day -7 to Day -1) before the patient receives their first infusion of CA9hi-1.
Key exclusion criteria (12 listed)
- Ongoing toxic manifestations of previous treatments (Grade 2 or greater according to NCI-CTCAE v4.02) with the exception of alopecia or certain Grade 2 toxicities, which in the opinion of the investigator and CDD should not exclude the patient - these should be discussed on a case by case basis
- Symptomatic brain metastases or spinal cord compression
- Patients who have received prior radiotherapy to their lungs will not be eligible for this trial.
- Female patients who are able to become pregnant (or already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral; injected or implanted hormonal contraception and condom; have an intra-uterine device and condom; diaphragm with spermicidal gel and condom) effective at the first administration of CA9hu-1, throughout the trial and for six months afterwards are considered eligible. Breast feeding should be discontinued if the mother is treated with CA9hu-1.
- Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] effective at the first administration of hu-CA91, throughout the trial and for six months afterwards). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example: condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
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 |
|---|---|---|
| CA9hu-1Humanized monoclonal antibody to human carbonic anhydrase IX | Drug | Treatment arm |
Primary outcome
Number of adverse events to CA9hi-1 and grading their severity according to the National Cancer Institute's Common Terminology Criteria for adverse Events (NCI CTCAE) Version 4.02.
Time frame: 6 months
The primary objective of this outcome is to establish the safety and toxicity profile of hu-CA91.
Number of patients reaching the dose levels of 750 mg of CA9hu-1 without any dose limiting toxicities.
Time frame: 4 weeks
The objective of this outcome is to perform a dose escalation of of CA9hu-1 to levels of 750mg without any dose limiting toxicities.
Number of patients reaching pharmacologically active dose measurement of CA9hu-1
Time frame: 4 weeks
The objective of this outcome is to determine number of patients in whom the pharmacologically active dose of CA9hu-1 wil be reached by measurement of plasma concentrations of the CA9hu-1. In order to reach the proposed pharmacologically active dose, the plasma levels of 200 +/- 100 nM are necessary.
Maximum tolerated dose of CA91hu-1
Time frame: 4 weeks
The objective is to determine a dose at which no more than one patient out of up to six patients at the same dose level experience a highly probable or probable CA9hu-1 related dose limiting toxicity.
6 secondary outcomes
Half-life of CA9-hu-1
Time frame: 4 weeks
Peak Plasma Concentration (Cmax) of CA9hu-1
Time frame: 4 weeks
Area under the plasma concentration versus time curve (AUC)
Time frame: 4 weeks
Anti-drug antibodies
Time frame: 6 months
Anti-tumour activity of CA9hu-1
Time frame: 6 months
Biomarker for detection of early tumour response
Time frame: 6 months
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 15 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CA9hu-1 in people with Clear Cell Renal Cell Carcinoma Metastatic and TNBC - Triple-Negative Breast Cancer, run by Mabpro, a.s..
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of adverse events to CA9hi-1 and grading their severity according to the National Cancer Institute's Common Terminology Criteria for adverse Events (NCI CTCAE) Version 4.02. (time frame: 6 months). The study lists 4 primary outcomes in all. 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 15 Mar 2023.